Publications by authors named "Domagoj Coric"

53 Publications

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.

Int J Spine Surg 2021 Jul 19. Epub 2021 Jul 19.

Center for Disc Replacement at Texas Back Institute, Plano, Texas.

Background: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration.

Methods: This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI.

Results: The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation.

Conclusions: The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration.

Clinical Relevance: This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion.

Level Of Evidence: 2.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/8084DOI Listing
July 2021

Patient-reported outcome improvements at 24-month follow-up after fusion added to decompression for grade I degenerative lumbar spondylolisthesis: a multicenter study using the Quality Outcomes Database.

J Neurosurg Spine 2021 Apr 16:1-10. Epub 2021 Apr 16.

16Department of Neurological Surgery, University of California, San Francisco, California.

Objective: The ideal surgical management of grade I lumbar spondylolisthesis has not been determined despite extensive prior investigations. In this cohort study, the authors used data from the large, multicenter, prospectively collected Quality Outcomes Database to bridge the gap between the findings in previous randomized trials and those in a more heterogeneous population treated in a typical practice. The objective was to assess the difference in patient-reported outcomes among patients undergoing decompression alone or decompression plus fusion.

Methods: The primary outcome measure was change in 24-month Oswestry Disability Index (ODI) scores. The minimal clinically important difference (MCID) in ODI score change and 30% change in ODI score at 24 months were also evaluated. After adjusting for patient-specific and clinical factors, multivariable linear and logistic regressions were employed to evaluate the impact of fusion on outcomes. To account for differences in age, sex, body mass index, and baseline listhesis, a sensitivity analysis was performed using propensity score analysis to match patients undergoing decompression only with those undergoing decompression and fusion.

Results: In total, 608 patients who had grade I lumbar spondylolisthesis were identified (85.5% with at least 24 months of follow-up); 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-month change in ODI score was significantly greater in the fusion plus decompression group than in the decompression-only group (-25.8 ± 20.0 vs -15.2 ± 19.8, p < 0.001). Fusion remained independently associated with 24-month ODI score change (B = -7.05, 95% CI -10.70 to -3.39, p ≤ 0.001) in multivariable regression analysis, as well as with achieving the MCID for the ODI score (OR 1.767, 95% CI 1.058-2.944, p = 0.029) and 30% change in ODI score (OR 2.371, 95% CI 1.286-4.371, p = 0.005). Propensity score analysis resulted in 94 patients in the decompression-only group matched 1 to 1 with 94 patients in the fusion group. The addition of fusion to decompression remained a significant predictor of 24-month change in the ODI score (B = 2.796, 95% CI 2.228-13.275, p = 0.006) and of achieving the 24-month MCID ODI score (OR 2.898, 95% CI 1.214-6.914, p = 0.016) and 24-month 30% change in ODI score (OR 2.300, 95% CI 1.014-5.216, p = 0.046).

Conclusions: These results suggest that decompression plus fusion in patients with grade I lumbar spondylolisthesis may be associated with superior outcomes at 24 months compared with decompression alone, both in reduction of disability and in achieving clinically meaningful improvement. Longer-term follow-up is warranted to assess whether this effect is sustained.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2020.9.SPINE201082DOI Listing
April 2021

Impact of surgeon and hospital factors on surgical decision-making for grade 1 degenerative lumbar spondylolisthesis: a Quality Outcomes Database analysis.

J Neurosurg Spine 2021 Feb 19:1-11. Epub 2021 Feb 19.

1Department of Neurological Surgery, University of Miami, Florida.

Objective: Surgical treatment for degenerative spondylolisthesis has been proven to be clinically challenging and cost-effective. However, there is a range of thresholds that surgeons utilize for incorporating fusion in addition to decompressive laminectomy in these cases. This study investigates these surgeon- and site-specific factors by using the Quality Outcomes Database (QOD).

Methods: The QOD was queried for all cases that had undergone surgery for grade 1 spondylolisthesis from database inception to February 2019. In addition to patient-specific covariates, surgeon-specific covariates included age, sex, race, years in practice (0-10, 11-20, 21-30, > 30 years), and fellowship training. Site-specific variables included hospital location (rural, suburban, urban), teaching versus nonteaching status, and hospital type (government, nonfederal; private, nonprofit; private, investor owned). Multivariable regression and predictor importance analyses were performed to identify predictors of the treatment performed (decompression alone vs decompression and fusion). The model was clustered by site to account for site-specific heterogeneity in treatment selection.

Results: A total of 12,322 cases were included with 1988 (16.1%) that had undergone decompression alone. On multivariable regression analysis clustered by site, adjusting for patient-level clinical covariates, no surgeon-specific factors were found to be significantly associated with the odds of selecting decompression alone as the surgery performed. However, sites located in suburban areas (OR 2.32, 95% CI 1.09-4.84, p = 0.03) were more likely to perform decompression alone (reference = urban). Sites located in rural areas had higher odds of performing decompression alone than hospitals located in urban areas, although the results were not statistically significant (OR 1.33, 95% CI 0.59-2.61, p = 0.49). Nonteaching status was independently associated with lower odds of performing decompression alone (OR 0.40, 95% CI 0.19-0.97, p = 0.04). Predictor importance analysis revealed that the most important determinants of treatment selection were dominant symptom (Wald χ2 = 34.7, accounting for 13.6% of total χ2) and concurrent diagnosis of disc herniation (Wald χ2 = 31.7, accounting for 12.4% of total χ2). Hospital teaching status was also found to be relatively important (Wald χ2 = 4.2, accounting for 1.6% of total χ2) but less important than other patient-level predictors.

Conclusions: Nonteaching centers were more likely to perform decompressive laminectomy with supplemental fusion for spondylolisthesis. Suburban hospitals were more likely to perform decompression only. Surgeon characteristics were not found to influence treatment selection after adjustment for clinical covariates. Further large database registry experience from surgeons at high-volume academic centers at which surgically and medically complex patients are treated may provide additional insight into factors associated with treatment preference for degenerative spondylolisthesis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2020.8.SPINE201015DOI Listing
February 2021

A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study.

J Neurosurg Spine 2021 Feb 5:1-10. Epub 2021 Feb 5.

7InVivo Therapeutics Corp., Cambridge, Massachusetts.

Objective: The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2-12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.

Methods: This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.

Results: Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.

Conclusions: In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.Clinical trial registration no.: NCT02138110 (clinicaltrials.gov).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2020.8.SPINE191507DOI Listing
February 2021

"July Effect" Revisited: July Surgeries at Residency Training Programs are Associated with Equivalent Long-term Clinical Outcomes Following Lumbar Spondylolisthesis Surgery.

Spine (Phila Pa 1976) 2021 Jun;46(12):836-843

Department of Neurological Surgery, University of California, San Francisco, Ca.

Study Design: Retrospective analysis of a prospective registry.

Objective: We utilized the Quality Outcomes Database (QOD) registry to investigate the "July Effect" at QOD spondylolisthesis module sites with residency trainees.

Summary Of Background Data: There is a paucity of investigation on the long-term outcomes following surgeries involving new trainees utilizing high-quality, prospectively collected data.

Methods: This was an analysis of 608 patients who underwent single-segment surgery for grade 1 degenerative lumbar spondylolisthesis at 12 high-enrolling sites. Surgeries were classified as occurring in July or not in July (non-July). Outcomes collected included estimated blood loss, length of stay, operative time, discharge disposition, complications, reoperation and readmission rates, and patient-reported outcomes (Oswestry Disability Index [ODI], Numeric Rating Scale [NRS] Back Pain, NRS Leg Pain, EuroQol-5D [EQ-5D] and the North American Spine Society [NASS] Satisfaction Questionnaire). Propensity score-matched analyses were utilized to compare postoperative outcomes and complication rates between the July and non-July groups.

Results: Three hundred seventy-one surgeries occurred at centers with a residency training program with 21 (5.7%) taking place in July. In propensity score-matched analyses, July surgeries were associated with longer operative times ( average treatment effect = 22.4 minutes longer, 95% confidence interval 0.9-449.0, P = 0.041). Otherwise, July surgeries were not associated with significantly different outcomes for the remaining perioperative parameters (estimated blood loss, length of stay, discharge disposition, postoperative complications), overall reoperation rates, 3-month readmission rates, and 24-month ODI, NRS back pain, NRS leg pain, EQ-5D, and NASS satisfaction score (P > 0.05, all comparisons).

Conclusion: Although July surgeries were associated with longer operative times, there were no associations with other clinical outcomes compared to non-July surgeries following lumbar spondylolisthesis surgery. These findings may be due to the increased attending supervision and intraoperative education during the beginning of the academic year. There is no evidence that the influx of new trainees in July significantly affects long-term patient-centered outcomes.Level of Evidence: 3.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/BRS.0000000000003903DOI Listing
June 2021

Editors' Introduction: Modern Technology Applications in Minimally Invasive Spine Surgery Techniques.

Int J Spine Surg 2020 Dec;14(s3):S3

Department of Neurosurgery & Rehabilitation Medicine, University of Miami Miller School of Medicine, Miami, Florida.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735468PMC
December 2020

Expandable Interbody Spacers: A Two-Year Study Evaluating Radiologic and Clinical Outcomes With Patient-Reported Outcomes.

Int J Spine Surg 2020 Dec 29;14(s3):S31-S38. Epub 2020 Oct 29.

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Background: Posterior and transforaminal lumbar interbody fusion (PLIF and TLIF) have gained significant popularity for management of lumbar degenerative spine over the last 3 decades. Expandable interbody spacers are a newer technology that can increase in size after placement, theoretically minimizing the operative risks of static spacers without sacrificing radiographic correction. The goal of this study is to further evaluate the radiographic and clinical outcomes of expandable spacers.

Methods: This was a retrospective analysis of a prospective cohort that underwent elective 1- to 3-level PLIF/TLIF with expandable interbody spacers from 2014 to 2020 at a single institution. Patient-reported outcome measures (PROMs) Oswestry Disability Index and Visual Analog Scale were collected at 6 weeks, 3 months, 6 months, and 12 months. Imaging was performed at 12 months, with follow up at 24 months in case of nonunion. Retrospective outcomes were computer tomography (CT) based and Bridwell-Lenke classification of fusion, radiographic parameters, and adverse events.

Results: A total of 50/53 (94.3%) otherwise eligible patients had 12-month PROMs and CT imaging for analysis. Here, 50% were obese (body mass index > 30), 58% had a smoking history, and 24% had a prior lumbar procedure. Also, 46/50 (92%) patients fused by CT criteria. Significant decrease in PROMs was seen as early as 6 weeks postoperatively. The mean change in preoperative-to-postoperative global lordosis values was 3.8° ± 15.6°. There were 4 (8%) intraoperative durotomies and 5 (10%) patients requiring reoperation for nonunion.

Conclusions: Our study demonstrates the use of expandable spacers in a high comorbidity cohort with low complications, excellent improvement in PROMs despite minimal lordotic improvement, and high rates of fusion without recombinant human bone morphogenetic protein-2 (rhBMP-2) or iliac crest bone graft.

Level Of Evidence: 4.

Clinical Relevance: Expandable interbody fusion can significantly improve outcomes for degenerative lumbar spondylosis, with good safety profile, and high fusion rates.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735441PMC
December 2020

Percutaneous, Navigated Minimally Invasive Posterior Cervical Pedicle Screw Fixation.

Int J Spine Surg 2020 Dec 29;14(s3):S14-S21. Epub 2020 Oct 29.

Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.

Background: Cervical pedicle screws provide significant biomechanical advantage but can be technically challenging and associated with morbid exposure. Improvements in intraoperative navigation guidance and instrumentation have made feasible this biomechanically robust, but technically challenging procedure. We present our initial experience with minimally invasive (MIS) percutaneous pedicle screw fixation in the cervical atlantoaxial and subaxial spine.

Methods: A retrospective review was performed on 27 cases that involved a novel MIS percutaneous cervical pedicle screw technique. Small lateral skin incisions were made bilaterally on the neck using intraoperative navigation guidance. Subsequently, navigated, percutaneous screws were placed using the Proficient Minimally Invasive System (PROMIS; Spine Wave, Shelton, CT). Computed tomography (CT)-guided navigation was used for cervical pedicle screw placement with subsequent placement of percutaneous rods.

Results: Indications for surgery included type II odontoid fractures, subaxial fracture dislocations and burst fracture, metastatic pathological burst fracture, and degenerative spondylosis with stenosis. There were 15 men and 12 women, with an average age 63.5 years. Follow-up ranged from 3 to 24 months (average = 16.7 months). One screw was revised intraoperatively. Two patients (7.7%) required reoperation, 1 patient required repositioning of a C5 pedicle screw, and 1 suffered a C7 body fracture. No nerve root injury, spinal cord injury, or vertebral artery injuries were reported.

Conclusions: Percutaneous cervical pedicle screw fixation is a feasible and safe technique when performed with CT-guided intraoperative navigation techniques. Cervical pedicle screw fixation provides a biomechanically superior construct in comparison with a lateral mass technique. In addition, the lack of paraspinal muscle disruption preserves important stabilizers of the posterior ligamentous complex and may reduce wound-healing issues in high-risk cases (eg, trauma patients). Although the current role for percutaneous instrumentation is relatively narrow, the advancement of MIS posterior cervical techniques may provide expanded opportunities in the future.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7122DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735464PMC
December 2020

Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance.

Int J Spine Surg 2020 Dec 29;14(s3):S22-S30. Epub 2020 Oct 29.

Telos Partners, LLC, Salt Lake City, Utah.

Background: Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device.

Methods: This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE).

Results: There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points ( < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions.

Conclusions: The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages.

Level Of Evidence: 4.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735440PMC
December 2020

Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 1: An Editorial on Their Biomechanical Characteristics.

Int J Spine Surg 2020 Dec 29;14(s3):S63-S67. Epub 2020 Oct 29.

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Background: Bidirectional expandable designs for lumbar interbody fusion cages are the latest iteration of expandable spacers employed to address some of the common problems inherent to static interbody fusion cages.

Objective: To describe the rationales for contemporary bidirectional, multimaterial expandable lumbar interbody fusion cage designs to achieve in situ expansion for maximum anterior column support while decreasing insertion size during minimal-access surgeries.

Methods: The authors summarize the current concepts behind expandable spinal fusion open architecture cage designs focusing on advanced minimally invasive spinal surgery techniques, such as endoscopy. A cage capable of bidirectional expansion in both height and width to address constrained surgical access problems was of particular interest to the authors while they analyzed the relationship between implant material stiffness and geometric design regarding the risk of subsidence and reduced graft loading.

Conclusions: Biomechanical advantages of new bidirectional, multimaterial expandable interbody fusion cages allow insertion through minimal surgical access and combine the advantages of proven device configurations and advanced material selection. The final construct stiffness is sufficient to provide immediate anterior column support while accommodating reduced sizes required for minimally invasive surgery applications.

Level Of Evidence: 7.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735463PMC
December 2020

Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage.

Int J Spine Surg 2020 Dec 29;14(s3):S68-S74. Epub 2020 Oct 29.

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Background: Expandable cages that allow for bidirectional expansion, in both height and width, may offer benefits over traditional expandable cages or static cages. Effective stiffness must also be considered, as implants with exceedingly high stiffness may increase subsidence risk and reduce graft loading.

Methods: A retrospective case series of 7 patients were assessed with computed tomography (CT) scan at the final 1-year follow-up to evaluate the interbody fusion and configuration of the expandable cage related to the endplates within the intervertebral space. CT scans were reformatted using cage's tantalum markers as fiducials for single-plane orientation for each intervertebral cage. Device height and width at maximum in situ expansion was measured at its anterior and posterior aspects to evaluate implant deformation. The new bone volume within each cage was measured from the same CT scan data sets and by the Bridwell classification of interbody fusion.

Results: The average difference between medial and lateral height measurements was 1.82 mm (±1.08) at the device's anterior aspect and 1.41 mm (±0.98) at the posterior aspect. The average difference between medial and lateral heights was 18.55% (±9.34) anteriorly and 15.49% (±9.24) posteriorly. There was a successful fusion in all 7 patients, as evidenced by measurable bone volume in the center of each interbody cage with an average of 586.42 mm (±237.06).

Conclusion: The authors demonstrated the feasibility of successfully using bidirectionally expandable multimaterial cages to achieve interbody fusion. These composite open-architecture cages were found to conform to each patient's endplate configuration. The authors' observations support the concept of material selection impacting the effective construct stiffness. The design investigated by the authors provided sufficient anterior column support and successful fusion in all patients.

Level Of Evidence: 4.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735472PMC
December 2020

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study.

Spine J 2021 02 21;21(2):239-252. Epub 2020 Oct 21.

OrthoCarolina, 2001 Randolph Rd, Charlotte, NC 28207, USA.

Background Context: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.

Purpose: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy.

Study Design/setting: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial.

Patient Sample: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF.

Outcome Measures: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months.

Methods: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls).

Results: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups.

Conclusions: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.spinee.2020.10.014DOI Listing
February 2021

Complications and Complication Avoidance With Cervical Total Disc Replacement.

Int J Spine Surg 2020 Aug;14(s2):S50-S56

Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.

Complications with cervical arthroplasty can be generalized to errors in patient selection or surgical technique. Patients with advanced spondylosis or osteophytic disease, severe facet arthropathy, osteoporosis, sagittal deformity, or preoperative instability are poor candidates for arthroplasty and are more prone to complications. Poor surgical technique can result in subsidence, expulsion, and kyphosis, and it can contribute to heterotopic ossification. Additionally, all of the inherent complications from an anterior cervical approach may occur with cervical artificial disc placement. This article will focus on the complications uniquely associated with cervical arthroplasty.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14444/7091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528766PMC
August 2020

Commentary: The Effect of T1-Slope in Spinal Parameters After Cervical Disc Arthroplasty.

Authors:
Domagoj Coric

Neurosurgery 2020 Jul 25. Epub 2020 Jul 25.

Carolina Neurosurgery and Spine Associates, Atrium Musculoskeletal Institute, Charlotte, North Carolina.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyaa290DOI Listing
July 2020

Cervical Arthroplasty: Long-Term Outcomes of FDA IDE Trials.

Global Spine J 2020 Apr 28;10(2 Suppl):61S-64S. Epub 2020 May 28.

Carolinas Medical Center, Charlotte, NC, USA.

Study Design: Special Issues MIS/Navigation.

Objectives: Over the past decade, cervical total disc replacement has been established in numerous randomized clinical trials as an alternative to anterior cervical discectomy and fusion. The purpose of this review is to evaluate the long-term outcomes after cervical arthroplasty.

Methods/results: Early outcomes (studies with 2-year follow-up) after arthroplasty established the efficacy of total disc replacement and, more recently, long-term studies have shown the durability of these good clinical outcomes. Biomechanical and clinical data have demonstrated that this motion preservation technology decreases adjacent-level stresses compared with fusion. Additionally, long-term outcomes as well as outcomes after multilevel arthroplasty have now established the role of arthroplasty in select patient populations, namely patients with 1- and 2-level spondylosis/stenosis causing radiculopathy from C3-7.

Conclusions: Data on adjacent segment deterioration and adjacent segment reoperation remains controversial but suggest a positive effect after arthroplasty. But these are multifactorial issues and we still do not fully understand all the factors affecting adjacent segment pathology and longer-term studies after arthroplasty will continue to address this issue.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2192568219898154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263333PMC
April 2020

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 Jun 4. Epub 2020 Jun 4.

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated.

Objective: To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis.

Methods: A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change.

Results: The mean age was 64.2 ± 11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [-12.9 to -2.6]; P = .003), NRS back pain change (β -1.2; 95% CI [-2.1 to -0.4]; P = .004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 3.7; 95% CI [1.7-8.3]; P < .001). Increasing age was associated with superior NRS leg pain change (β -0.1; 95% CI [-0.1 to -0.01]; P = .03) and NASS satisfaction (OR = 1.05; 95% CI [1.01-1.09]; P = .02). Fusion surgeries were associated with superior ODI change (β -6.7; 95% CI [-12.7 to -0.7]; P = .03), NRS back pain change (β -1.1; 95% CI [-2.1 to -0.2]; P = .02), and NASS satisfaction (OR = 3.6; 95% CI [1.6-8.3]; P = .002).

Conclusion: Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyaa206DOI Listing
June 2020

A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database.

Neurosurgery 2020 09;87(3):555-562

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness.

Objective: To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size.

Methods: We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively.

Results: A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P < .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P < .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P < .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P > .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = -4.7; 95% CI = -9.3 to -0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance.

Conclusion: For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyaa097DOI Listing
September 2020

Correlation of return to work with patient satisfaction after surgery for lumbar spondylolisthesis: an analysis of the Quality Outcomes Database.

Neurosurg Focus 2020 05;48(5):E5

17Geisinger Health, Danville, Pennsylvania.

Objective: Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction.

Methods: The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW.

Results: Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1-2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3-4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]).

Conclusions: There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2020.2.FOCUS191022DOI Listing
May 2020

Regional Variance in Disability and Quality-of-Life Outcomes After Surgery for Grade I Degenerative Lumbar Spondylolisthesis: A Quality Outcomes Database Analysis.

World Neurosurg 2020 06 28;138:e336-e344. Epub 2020 Feb 28.

Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah, USA. Electronic address:

Objective: Regional differences in outcomes after spine surgery are poorly understood. We assessed disability and quality-of-life outcomes by geographic region in the United States using the NeuroPoint Alliance Quality Outcomes Database.

Methods: We queried the prospective Quality Outcomes Database patient registry to identify patients who underwent elective 1- or 2-level lumbar surgery for grade I degenerative spondylolisthesis from July 2014 through June 2016. Primary outcome measures included Oswestry Disability Index (ODI) and EuroQOL-5D (EQ-5D) reported at 24 months postoperatively. Differences in EQ-5D and ODI were compared across geographic regions of the United States (Northeast, Midwest, South, West).

Results: We identified 608 patients from 12 centers who underwent surgery. Of these, 517 (85.0%) had ODI data and 492 (80.9%) had EQ-5D data at 24 months. Southern states had the largest representation (304 patients; 5 centers), followed by Northeastern (114 patients; 3 centers), Midwestern (96 patients; 2 centers), and Western (94 patients; 2 centers) states. Baseline ODI scores were significantly different among regions, with the South having the greatest baseline disability burden (Northeast: 40.9 ± 16.9, South: 51.2 ± 15.8, Midwest: 40.9 ± 17.8, West: 45.0 ± 17.1, P < 0.001). The change in ODI at 24 months postoperatively was significantly different among regions, with the South showing the greatest ODI improvement (Northeast: -21.1 ± 18.2, South: -26.5 ± 20.2, Midwest: -18.2 ± 22.9, West: -21.7 ± 19.6, P < 0.001). All regions had ≥60% achievement of the minimum clinically important difference in ODI at 24 months postoperatively. No regional differences were observed for EQ-5D.

Conclusion: Significant regional variation exists for disability outcomes, but not quality of life, at 24 months after spinal surgery for grade I degenerative spondylolisthesis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.wneu.2020.02.117DOI Listing
June 2020

Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database.

Spine (Phila Pa 1976) 2020 Jul;45(14):1000-1008

Department of Neurological Surgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, UT.

Study Design: Prospective database analysis.

Objective: To assess the effect of age on patient-reported outcomes (PROs) and complication rates after surgical treatment for spondylolisthesis SUMMARY OF BACKGROUND DATA.: Degenerative lumbar spondylolisthesis affects 3% to 20% of the population and up to 30% of the elderly. There is not yet consensus on whether age is a contraindication for surgical treatment of elderly patients.

Methods: The Quality Outcomes Database lumbar registry was used to evaluate patients from 12 US academic and private centers who underwent surgical treatment for grade 1 lumbar spondylolisthesis between July 2014 and June 2016.

Results: A total of 608 patients who fit the inclusion criteria were categorized by age into the following groups: less than 60 (n = 239), 60 to 70 (n = 209), 71 to 80 (n = 128), and more than 80 (n = 32) years. Older patients showed lower mean body mass index (P < 0.001) and higher rates of diabetes (P = 0.007), coronary artery disease (P = 0.0001), and osteoporosis (P = 0.005). A lower likelihood for home disposition was seen with higher age (89.1% in <60-year-old vs. 75% in >80-year-old patients; P = 0.002). There were no baseline differences in PROs (Oswestry Disability Index, EuroQol health survey [EQ-5D], Numeric Rating Scale for leg pain and back pain) among age categories. A significant improvement for all PROs was seen regardless of age (P < 0.05), and most patients met minimal clinically important differences (MCIDs) for improvement in postoperative PROs. No differences in hospital readmissions or reoperations were seen among age groups (P < 0.05). Multivariate analysis demonstrated that, after controlling other variables, a higher age did not decrease the odds of achieving MCID at 12 months for the PROs.

Conclusion: Our results indicate that well-selected elderly patients undergoing surgical treatment of grade 1 spondylolisthesis can achieve meaningful outcomes. This modern, multicenter US study reflects the current use and limitations of spondylolisthesis treatment in the elderly, which may be informative to patients and providers.

Level Of Evidence: 4.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/BRS.0000000000003441DOI Listing
July 2020

Anterior Cervical Discectomy and Fusion in the Outpatient Ambulatory Surgery Setting: Analysis of 2000 Consecutive Cases.

Neurosurgery 2020 03;86(3):E310-E315

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Background: In an effort to improve efficiency of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and rarely requires overnight stays in the hospital, supporting its migration to the ASC. Recent analyses have called into question the safety of outpatient ACDF, potentially slowing its adoption. ASC-ACDF studies have largely been limited to small series, precluding an accurate assessment of safety.

Objective: To analyze 2000 ASC-ACDF cases, describe patient selection and perioperative protocol, and report associated safety profile.

Methods: A total of 2000 patients who underwent 1 to 3 level ACDF in a single ASC from 2006 to 2018 were included in this retrospective analysis. Patients were observed in a 4-h postanesthesia care unit (PACU) with a multimodal pain management regiment. Data were collected on patient demographics, comorbidities, operative details, and 30- and 90-d morbidity.

Results: Of the 2000 patients, 10 (0.5%) required transfer to an inpatient setting within the 4-h observation. Reasons for transfer included hematoma (2), pain control (2), cerebrospinal fluid leak (1), and medical complications (5). Six patients (0.3%) underwent reoperation within 30 d. All-cause 30-d readmission was 1.9%.

Conclusion: An analysis of 2000 ACDF patients in an ASC setting with a standardized perioperative protocol demonstrates that surgical complications occur at a low rate (<1%) and can be appropriately diagnosed and managed in a 4-h PACU. In an effort to decrease healthcare costs, surgeons can safely perform ACDFs in an ASC utilizing patient selection criteria and perioperative management protocols similar to those reported here.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyz514DOI Listing
March 2020

Outpatient anterior cervical discectomy and fusion in the ambulatory surgery center setting: safety assessment for the Medicare population.

J Neurosurg Spine 2019 Nov 15:1-6. Epub 2019 Nov 15.

Objective: Several studies have demonstrated that anterior cervical discectomy and fusion (ACDF) surgery in the outpatient versus hospital setting provides improved efficiency, cost-effectiveness, and patient satisfaction without a compromise in safety or outcome. Recent anecdotal reports, however, have questioned whether outpatient ACDF surgery is safe in the > 65-year-old Medicare population. To date, no clinical study has assessed the safety of outpatient ACDF in an ambulatory surgery center (ASC), specifically in a Medicare population. The authors set out to analyze their 3-year experience with Medicare-enrolled patients undergoing ACDF surgery at a single ASC to determine its safety profile, perioperative care protocol, and associated outcomes.

Methods: A retrospective analysis of 119 consecutive patients > 65 years (Medicare-eligible) who underwent 1-, 2-, or 3-level ACDF at a single ASC from 2015 to 2018 (since Medicare payment approval) was conducted. All patients were in American Society of Anesthesiologists classes I-III. Postoperatively, patients were observed for a minimum of 4 hours in a recovery setting for the following factors: neck swelling, neurological status, ability to swallow solid food, and urination capacity. All patients received a multimodal pain management regimen prior to discharge home. Data were collected on patient demographics, comorbidities, operative details, and all perioperative and 90-day morbidity.

Results: Complete data were available for all 119 consecutive Medicare-eligible patients, 97 (81.5%) of whom were actively enrolled in Medicare. One-, 2-, and 3-level ACDFs were performed in 103 (86.6%), 15 (12.6%), and 1 (0.8%) patients, respectively. No patients required return to the operating room for intervention within the 4-hour postanesthesia care unit observation window. No patients required transfer from the ASC to the hospital setting for further observation or intervention. Thirty-day adverse events were reported in 2.4% of cases, all of which resolved by 90 days after surgery. The incidence of 90-day hospital readmission was 1.7% (n = 2), with 1 patient (0.8%) requiring reoperation at the index level for deep infection. All-cause 90-day mortality was 0%.

Conclusions: An analysis of consecutive Medicare patients (American Society of Anesthesiologists classes I-III) who underwent mostly 1-level and some 2-level ACDFs in an ASC setting demonstrates that surgical complications occur at a low rate with a safety profile similar to that reported for both inpatient ACDF and patients younger than 65 years. In an effort to reduce cost and improve efficiency of care, surgeons can safely perform ACDF in the Medicare population in an ASC environment utilizing patient selection criteria and perioperative management similar to those reported here.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2019.7.SPINE19480DOI Listing
November 2019

Sexual Dysfunction: Prevalence and Prognosis in Patients Operated for Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 08;87(2):200-210

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: There is a paucity of investigation on the impact of spondylolisthesis surgery on back pain-related sexual inactivity.

Objective: To investigate predictors of improved sex life postoperatively by utilizing the prospective Quality Outcomes Database (QOD) registry.

Methods: A total of 218 patients who underwent surgery for grade 1 degenerative lumbar spondylolisthesis were included who were sexually active. Sex life was assessed by Oswestry Disability Index item 8 at baseline and 24-mo follow-up.

Results: Mean age was 58.0 ± 11.0 yr, and 108 (49.5%) patients were women. At baseline, 178 patients (81.7%) had sex life impairment. At 24 mo, 130 patients (73.0% of the 178 impaired) had an improved sex life. Those with improved sex lives noted higher satisfaction with surgery (84.5% vs 64.6% would undergo surgery again, P = .002). In multivariate analyses, lower body mass index (BMI) was associated with improved sex life (OR = 1.14; 95% CI [1.05-1.20]; P < .001). In the younger patients (age < 57 yr), lower BMI remained the sole significant predictor of improvement (OR = 1.12; 95% CI [1.03-1.23]; P = .01). In the older patients (age ≥ 57 yr)-in addition to lower BMI (OR = 1.12; 95% CI [1.02-1.27]; P = .02)-lower American Society of Anesthesiologists (ASA) grades (1 or 2) (OR = 3.7; 95% CI [1.2-12.0]; P = .02) and ≥4 yr of college education (OR = 3.9; 95% CI [1.2-15.1]; P = .03) were predictive of improvement.

Conclusion: Over 80% of patients who present for surgery for degenerative lumbar spondylolisthesis report a negative effect of the disease on sex life. However, most patients (73%) report improvement postoperatively. Sex life improvement was associated with greater satisfaction with surgery. Lower BMI was predictive of improved sex life. In older patients-in addition to lower BMI-lower ASA grade and higher education were predictive of improvement.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyz406DOI Listing
August 2020

A comparison of minimally invasive transforaminal lumbar interbody fusion and decompression alone for degenerative lumbar spondylolisthesis.

Neurosurg Focus 2019 05;46(5):E13

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVEThe optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.METHODSA total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.RESULTSThe mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF-as opposed to MIS decompression alone-was associated with superior ODI change (β = -7.59, 95% CI -14.96 to -0.23; p = 0.04), NRS back pain change (β = -1.54, 95% CI -2.78 to -0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12-0.82; p = 0.02).CONCLUSIONSFor symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2019.2.FOCUS18722DOI Listing
May 2019

Predictive model for long-term patient satisfaction after surgery for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

Neurosurg Focus 2019 05;46(5):E12

13Atlanta Brain and Spine Care, Atlanta, Georgia; and.

OBJECTIVESince the enactment of the Affordable Care Act in 2010, providers and hospitals have increasingly prioritized patient-centered outcomes such as patient satisfaction in an effort to adapt the "value"-based healthcare model. In the current study, the authors queried a prospectively maintained multiinstitutional spine registry to construct a predictive model for long-term patient satisfaction among patients undergoing surgery for Meyerding grade I lumbar spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients undergoing surgery for grade I lumbar spondylolisthesis between July 1, 2014, and June 30, 2016. The primary outcome of interest for the current study was patient satisfaction as measured by the North American Spine Surgery patient satisfaction index, which is measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. In order to identify predictors of higher satisfaction, the authors fitted a multivariable proportional odds logistic regression model for ≥ 2 years of patient satisfaction after adjusting for an array of clinical and patient-specific factors. The absolute importance of each covariate in the model was computed using an importance metric defined as Wald chi-square penalized by the predictor degrees of freedom.RESULTSA total of 502 patients, out of a cohort of 608 patients (82.5%) with grade I lumbar spondylolisthesis, undergoing either 1- or 2-level decompression (22.5%, n = 113) or 1-level decompression and fusion (77.5%, n = 389), met the inclusion criteria; of these, 82.1% (n = 412) were satisfied after 2 years. On univariate analysis, satisfied patients were more likely to be employed and working (41.7%, n = 172, vs 24.4%, n = 22; overall p = 0.001), more likely to present with predominant leg pain (23.1%, n = 95, vs 11.1%, n = 10; overall p = 0.02) but more likely to present with lower Numeric Rating Scale score for leg pain (median and IQR score: 7 [5-9] vs 8 [6-9]; p = 0.05). Multivariable proportional odds logistic regression revealed that older age (OR 1.57, 95% CI 1.09-2.76; p = 0.009), preoperative active employment (OR 2.06, 95% CI 1.27-3.67; p = 0.015), and fusion surgery (OR 2.3, 95% CI 1.30-4.06; p = 0.002) were the most important predictors of achieving satisfaction with surgical outcome.CONCLUSIONSCurrent findings from a large multiinstitutional study indicate that most patients undergoing surgery for grade I lumbar spondylolisthesis achieved long-term satisfaction. Moreover, the authors found that older age, preoperative active employment, and fusion surgery are associated with higher odds of achieving satisfaction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2019.2.FOCUS18734DOI Listing
May 2019

Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.

J Neurosurg Spine 2018 11;30(2):234-241

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVEThe AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2018.8.SPINE17913DOI Listing
November 2018

Obese Patients Benefit, but do not Fare as Well as Nonobese Patients, Following Lumbar Spondylolisthesis Surgery: An Analysis of the Quality Outcomes Database.

Neurosurgery 2020 01;86(1):80-87

Department of Neurological Surgery, University of California, San Francisco, California.

Background: Given recent differing findings following 2 randomized clinical trials on degenerative lumbar spondylolisthesis (DLS) surgery, there is a need to better define how subsets of patients fare following surgery.

Objective: To investigate the impact of obesity on patient-reported outcomes (PROs) following DLS surgery.

Methods: A total of 12 high-enrolling sites were queried, and we found 797 patients undergoing surgery for grade 1 DLS. For univariate comparisons, patients were stratified by BMI ≥ 30 kg/m2 (obese) and < 30 kg/m2 (nonobese). Baseline, 3-mo, and 12-mo follow-up parameters were collected. PROs included the North American Spine Society satisfaction questionnaire, numeric rating scale (NRS) back pain, NRS leg pain, Oswestry Disability Index (ODI), and EuroQoL-5D (EQ-5D) Questionnaire.

Results: We identified 382 obese (47.9%) and 415 nonobese patients (52.1%). At baseline, obese patients had worse NRS back pain, NRS leg pain, ODI, and EQ-5D scores (P < .001, P = .01, P < .001, and P = .02, respectively). Both cohorts improved significantly for back and leg pain, ODI, and EQ-5D at 12 mo (P < .001). At 12 mo, similar proportions of obese and nonobese patients responded that surgery met their expectations (62.6% vs 67.4%, P = .24). In multivariate analyses, BMI was independently associated with worse NRS leg pain and EQ-5D at 12 mo (P = .01 and P < .01, respectively) despite adjusting for baseline differences.

Conclusion: Obesity is associated with inferior leg pain and quality of life-but similar back pain, disability, and satisfaction-12 mo postoperatively. However, obese patients achieve significant improvements in all PRO metrics at 12 mo.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyy589DOI Listing
January 2020

Cervical Disc Arthroplasty: Current Evidence and Real-World Application.

Neurosurgery 2018 12;83(6):1087-1106

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant. We conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use. Search criteria were restricted to publications with a clinical patient population, excluding finite element analyses, biomechanical studies, cadaver studies, surgical technique-specific papers, and case studies. US publications mostly encompass the results of the highly controlled Food and Drug Administration Investigational Device Exemption trials. The predominantly level I evidence in the US literature supports the use of cTDR at 1 and 2 surgical levels when compared to anterior cervical discectomy and fusion. In general, the outside the US studies typically have smaller patient populations, are rarely controlled, and include broader surgical indications. Though these studies are of lower levels of evidence, they serve to advance patient indications in the use of cTDR. Complications such as secondary surgery, heterotopic ossification, and adjacent segment degeneration also remain a focus of studies. Other external challenges facing cTDR technology include regulatory restrictions and health economics, both of which are beginning to be addressed. Combined, the evidence for cTDR is robust supporting a variety of clinical indications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/neuros/nyx579DOI Listing
December 2018

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

J Neurosurg Spine 2018 03 5;28(3):252-261. Epub 2018 Jan 5.

8Texas Back Institute Research Foundation, Plano, Texas.

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2017.5.SPINE16824DOI Listing
March 2018

Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

Neurosurg Focus 2018 01;44(1):E2

2Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis. METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen's effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO. RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3-26.5 points for ODI, 0.04-0.3 points for EQ-5D, 0.6-4.5 points for NRS-LP, and 0.5-4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort. CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3171/2017.10.FOCUS17554DOI Listing
January 2018