Publications by authors named "Samuel B Adams"

150 Publications

Impact of Early Weightbearing After Ankle Arthroscopy and Bone Marrow Stimulation for Osteochondral Lesions of the Talus.

Orthop J Sports Med 2021 Sep 13;9(9):23259671211029883. Epub 2021 Sep 13.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina, USA.

Background: Osteochondral lesion of the talus (OLT) may be caused by osteochondritis dissecans, osteochondral fractures, avascular necrosis, or focal arthritic changes. For certain focal cartilage defects, bone marrow stimulation (BMS) has been a widely used technique to restore a fibrocartilage substitute overlying the defect. There are various postoperative weightbearing protocols for this procedure, with no single gold standard method.

Purpose: To retrospectively review the outcomes of patients undergoing ankle arthroscopy with concomitant BMS to determine outcomes based on postoperative weightbearing status.

Study Design: Cohort study; Level of evidence, 3.

Methods: We retrospectively reviewed the records of patients who underwent ankle arthroscopy with BMS for OLTs between 2015 and 2018. Patients were placed into 2 cohorts based on postoperative immobilization status: the nonweightbearing (NWB) group and the weightbearing-as-tolerated (WBAT) group. Patient characteristics obtained included age, sex, comorbidities, and etiology of talar pathology. Outcomes included the pain visual analog scale (VAS), range of motion (ROM), complications, time to first weightbearing, and the method and length of immobilization. Patients who were lost to follow-up before 30 days were excluded. The chi-square test was used to compare categorical variables between cohorts, and the test was used for continuous variables.

Results: A total of 69 patients met the inclusion criteria for this study, 18 in the WBAT group and 51 in the NWB group. The mean lesion size was 9.48 × 9.21 mm (range, 3-15 mm × 2-20 mm) for the NWB group and 9.36 × 9.72 mm (range, 5-14 mm × 6-20 mm) for the WBAT group ( > .05). The VAS scores improved from 4.40 to 0.67 for the WBAT group and from 6.33 to 2.55 for the NWB group, with the difference in final values reaching statistical significance ( = .0002). Postoperative ROM was not significantly different between the groups. There were 4 repeat operations within the NWB cohort.

Conclusion: The surgical management of OLTs can be challenging, and the postoperative weightbearing protocol can be an extra obstacle for the patient to navigate. We found no difference in pain, ROM, or complications when allowing immediate, full WBAT.
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http://dx.doi.org/10.1177/23259671211029883DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442498PMC
September 2021

Avascular Necrosis of the Talus After Subchondroplasty.

Foot Ankle Int 2021 09 22;42(9):1138-1143. Epub 2021 May 22.

Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.

Background: Subchondroplasty (SCP) is a relatively new procedure, developed in 2007 for the treatment of bone marrow lesions (BMLs), that has shown promising results in the knee through several different case series. The foot and ankle literature, however, is sparse, with only a few documented case reports or case series. At our institution, we have identified several patients with complications after this specific procedure. As a result, we report our case series of patients who developed talar avascular necrosis (AVN) after undergoing SCP.

Methods: A retrospective review was performed of patients who underwent SCP for a talar BML at our facility or who were referred to our facility after undergoing SCP at an outside institution. Patients were included if they developed radiographic evidence of talar AVN after the procedure. Patient demographics, comorbidities, concomitant intraoperative procedures, complications, and subsequent interventions were reviewed.

Results: Seven patients were identified as having radiographic evidence of talar AVN after SCP. Average time interval was 23 months postoperative from index procedure to radiographic confirmation of AVN. Two of the index procedures were performed at our institution, whereas 5 of the index procedures were performed at outside institutions and referred for further management. Three patients had documented risk factors for AVN before the SCP procedure. All 7 patients were symptomatic from the AVN.

Conclusion: We identified 7 patients who went on to develop talar AVN after having undergone SCP.

Level Of Evidence: Level IV, case series.
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http://dx.doi.org/10.1177/10711007211005435DOI Listing
September 2021

Three-dimensional Printing in Orthopaedic Surgery: Current Applications and Future Developments.

J Am Acad Orthop Surg Glob Res Rev 2021 04 20;5(4):e20.00230-11. Epub 2021 Apr 20.

From the Department of Orthopaedic Surgery, Duke University, Durham, NC.

Three-dimensional (3D) printing is an exciting form of manufacturing technology that has transformed the way we can treat various medical pathologies. Also known as additive manufacturing, 3D printing fuses materials together in a layer-by-layer fashion to construct a final 3D product. This technology allows flexibility in the design process and enables efficient production of both off-the-shelf and personalized medical products that accommodate patient needs better than traditional manufacturing processes. In the field of orthopaedic surgery, 3D printing implants and instrumentation can be used to address a variety of pathologies that would otherwise be challenging to manage with products made from traditional subtractive manufacturing. Furthermore, 3D bioprinting has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform how we treat patients with debilitating musculoskeletal injuries. Although costs can be high, as technology advances, the economics of 3D printing will improve, especially as the benefits of this technology have clearly been demonstrated in both orthopaedic surgery and medicine as a whole. This review outlines the basics of 3D printing technology and its current applications in orthopaedic surgery and ends with a brief summary of 3D bioprinting and its potential future impact.
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http://dx.doi.org/10.5435/JAAOSGlobal-D-20-00230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059996PMC
April 2021

Talonavicular Joint-Sparing 3D Printed Navicular Replacement for Osteonecrosis of the Navicular.

Foot Ankle Int 2021 09 31;42(9):1197-1204. Epub 2021 Mar 31.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA.

Pathology of the navicular can be a difficult entity to treat, particularly when the injury has progressed to osteonecrosis. While various nonoperative and operative modalities have been described, the emerging field of additive manufacturing has become a potential solution to this difficult problem in certain scenarios. While these implants have largely been used for fusion in the past, the concept of joint sparing with 3D printed implants is also emerging, and this case highlights a patient treated with a talonavicular joint-sparing, patient-specific 3D printed total navicular replacement.
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http://dx.doi.org/10.1177/10711007211002807DOI Listing
September 2021

Increasing age and modifiable comorbidities are associated with short-term complications after open reduction and internal fixation of ankle fractures.

Eur J Orthop Surg Traumatol 2021 Mar 23. Epub 2021 Mar 23.

Department of Orthopaedic Surgery, Duke University Medical Center, 4709 Creekstone Drive, Durham, NC, 27703, USA.

Background: Ankle fractures are common orthopedic injuries with complication rates fixation of up to 40%. Limited evidence exists in the literature regarding complications in the elderly population, and moreover, these studies frequently define elderly arbitrarily at 60-65 years old. The purpose of the present study was to utilize a large, validated database to evaluate whether there is an inflection point of age when postoperative complications after an ankle fracture significantly increase.

Methods: A retrospective review of all patients in the American College of Surgeons National Surgical Quality Improvement Program database who underwent fixation of an ankle fracture between 2012 and 2018 was performed. Patients were identified within the database using the Current Procedural Terminology codes. Appropriate statistical analysis was performed with p value less than 0.05 considered statistically significant.

Results: A total of 27,633 fractures were including and comprised of 221 posterior malleolar, 1567 medial malleolar, 8495 lateral malleolar, 10,175 bimalleolar, and 7175 trimalleolar. A total of 1545 complications were encountered (5.6%). There was a statistically significant association between increasing age and complications (OR = 1.03; p < 0.001). Further analysis shows the largest spike in complications within the age 78 + bracket. There were no overall interaction effects between age and fracture subtype (p = 0.223).

Conclusion: ORIF of ankle fractures is a common orthopedic procedure performed on patients of all ages, with complications ranging in severity. In order to best counsel patients on their individual postoperative risks, large datasets are often necessary to prognosticate. This study found that postoperative complications increase with advanced age. The incidence of complications did not spike for patients around the age of 65, but rather followed an incremental linear pattern with the largest increase in odds ratio occurring at age 78 and above. Complication rate was not associated with specific fracture type based off of ICD codes.
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http://dx.doi.org/10.1007/s00590-021-02927-zDOI Listing
March 2021

Effect of surface topography on in vitro osteoblast function and mechanical performance of 3D printed titanium.

J Biomed Mater Res A 2021 Oct 22;109(10):1792-1802. Epub 2021 Mar 22.

Department of Orthopaedic Surgery, Duke University, Durham, North Carolina, USA.

Critical-sized defects remain a significant challenge in orthopaedics. 3D printed scaffolds are a promising treatment but are still limited due to inconsistent osseous integration. The goal of the study is to understand how changing the surface roughness of 3D printed titanium either by surface treatment or artificially printing rough topography impacts the mechanical and biological properties of 3D printed titanium. Titanium tensile samples and discs were printed via laser powder bed fusion. Roughness was manipulated by post-processing printed samples or by directly printing rough features. Experimental groups in order of increasing surface roughness were Polished, Blasted, As Built, Sprouts, and Rough Sprouts. Tensile behavior of samples showed reduced strength with increasing surface roughness. MC3T3 pre-osteoblasts were seeded on discs and analyzed for cellular proliferation, differentiation, and matrix deposition at 0, 2, and 4 weeks. Printing roughness diminished mechanical properties such as tensile strength and ductility without clear benefit to cell growth. Roughness features were printed on mesoscale, unlike samples in literature in which roughness on microscale demonstrated an increase in cell activity. The data suggest that printing artificial roughness on titanium scaffold is not an effective strategy to promote osseous integration.
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http://dx.doi.org/10.1002/jbm.a.37172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373644PMC
October 2021

Fresh Osteochondral Allograft Transplantation for Osteochondral Lesions of the Talus: A Systematic Review.

J Foot Ankle Surg 2021 May-Jun;60(3):585-591. Epub 2021 Feb 9.

Associate Professor, Department of Orthopaedic Surgery, Duke University, Durham, NC.

Osteochondral lesions of the talus (OLTs) are difficult to treat. Despite a multitude of interventions, there are no generally-agreed-upon guidelines regarding treatment. The objective of this study was to conduct a systematic review of clinical outcomes after fresh osteochondral allografts transplantation of the talus. PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, and Medline were searched using PRISMA guidelines. Studies that evaluated outcomes after fresh osteochondral allograft transplantation for OLTs were included. Clinical outcomes, according to standardized scoring systems, such as the American Orthopaedics Foot & Ankle Society (AOFAS) Ankle/Hindfoot Scale and the Visual Analog Scale (VAS) were compared across studies. The literature search yielded 12 eligible studies with a mean Coleman Methodology Score of 68.1 (57-79). A total of 191 patients were included with an average age of 37.5 (17-74) years and average follow-up of 56.8 (6-240) months. The AOFAS Ankle/Hindfoot score was obtained pre- and postoperatively in 6 of the studies and had significant improvements in each (p < .05). Similarly, the VAS pain score was evaluated in 5 studies and showed significant decreases from pre- to postoperatively (p < .05). While there were no reported short-term complications, 21.6% of patients required minor subsequent procedures, most commonly arthroscopic debridement and hardware removal. The aggregate graft survival rate was 86.6%. Based on these findings, osteochondral allograft transplantation for OLTs results in positive outcomes with high rates of graft survival and patient satisfaction at intermediate follow-up.
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http://dx.doi.org/10.1053/j.jfas.2021.02.001DOI Listing
June 2021

Incidence and Risk Factors for Flap Coverage After Total Ankle Arthroplasty.

Foot Ankle Int 2021 Jun 1;42(6):744-749. Epub 2021 Feb 1.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA.

Background: Wound complications following total ankle arthroplasty (TAA) can have a significant impact on patient morbidity, particularly when they require flap coverage. We sought to determine the risk factors associated with the need for flap coverage after TAA and hypothesized that medical and operative risk factors such as diabetes and additional procedures would be associated with the need for flap coverage after TAA.

Methods: We performed a single-center retrospective review of TAAs from April 2007 to February 2019. Patient demographics and medical comorbidities were collected, in addition to other procedures performed at the time of TAA. Patients were stratified by the need for flap coverage, and unadjusted inferential statistics were performed to evaluate the risk factors associated with subsequent need for flap coverage.

Results: Among 2065 patients undergoing TAA, 28 (1.4%) patients required flap coverage after the index arthroplasty. Patients requiring flap coverage were older ( = .045), had higher Charlson comorbidity indices ( = .017), and had higher rates of diabetes and pulmonary disease ( = .038). Patients requiring flap coverage also had higher rates of additional procedures ( = .043, = .007). The most common flap was a radial forearm free flap, which was performed in 14 (50%) patients. Twenty-one patients (75%) requiring flap coverage had a stable, plantigrade foot at median 1.5-year follow-up.

Conclusion: Patient and operative risk factors, including advanced age, increased comorbidity burden, diabetes, pulmonary disease, and increased number of simultaneous procedures, were significantly associated with need for subsequent flap coverage. This should be considered as the indications for TAA expand.

Level Of Evidence: Level III, retrospective, prognostic cohort study.
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http://dx.doi.org/10.1177/1071100720982901DOI Listing
June 2021

Effect of Gender Differences on Patient-Reported Outcomes and Complications in Total Ankle Replacement.

Foot Ankle Int 2021 Jun 1;42(6):776-787. Epub 2021 Feb 1.

Department of Orthopaedics, Duke University Medical Center, Durham, NC, USA.

Background: The purpose of this study was to evaluate gender differences in patient outcomes and complications following total ankle replacement (TAR).

Methods: Consecutive patients who underwent primary TAR from July 2007 through May 2016 were prospectively followed and retrospectively reviewed. Demographic, operative, patient-reported outcomes (PROs), and complication data were collected and analyzed. PROs included the visual analog scale (VAS), 36-Item Short-Form Health Survey (SF-36), American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale, and Short Musculoskeletal Function Assessment (SMFA). A total of 475 patients were evaluated, including 248 males (52.2%) and 227 females (47.8%) with an average of 56.8 months follow-up.

Results: Women were more likely to have inflammatory arthritis (13.7% vs 2.8%; < .01) and significantly worse preoperative SF-36 total, SF-36 mental health component, AOFAS total, AOFAS pain, SMFA function, and SMFA bother scores (all < .05). Both genders demonstrated significant improvement in PROs at 1, 2, and 5 years. The magnitude of improvement was similar between genders for all PROs (all < .05) with the exception of SF-36 physical function, which was greater in men. Females underwent more nonrevision reoperations (32.2% vs 22.6%; = .0191), but there was no significant difference in failure rates (male 7.3% vs female 3.5%; = .07). The reoperation and failure rates at 2 years postoperation were 10.1% and 1.6% for men and 18.5% and 0.9% for women, respectively.

Conclusion: Women undergoing TAR were more likely to have worse preoperative PROs and higher rates of nonrevision reoperations, which remains true when controlling for their increased incidence of inflammatory arthritis. However, women reported similar improvements in PROs and had similar prosthetic survival rates as men. Increased understanding of these disparities, combined with gender-based interventions, may further advance patient outcomes.

Level Of Evidence: Level III, therapeutic, retrospective comparative series.
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http://dx.doi.org/10.1177/1071100720985292DOI Listing
June 2021

The Impact of Preoperative Mental Health and Depression on Outcomes After Total Ankle Arthroplasty.

J Bone Joint Surg Am 2021 Jan;103(2):131-138

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina.

Background: Preoperative mental health and depression have been shown to negatively impact patient-reported outcome measures after a broad array of orthopaedic procedures including total ankle arthroplasty. The hypothesis for this study was that decreased Short Form (SF)-36 Mental Component Summary (MCS) scores will modulate the impact of depression on patient-reported outcome measures after total ankle arthroplasty.

Methods: All patients undergoing primary total ankle arthroplasty between January 2007 and December 2016 who were enrolled into a prospective outcomes study and who had at least 1-year minimum study follow-up were retrospectively reviewed. Patients were separated into 4 groups based on the presence or absence of an SF-36 MCS score of <35 points and diagnosis of depression. SF-36 Physical Component Summary (PCS) and MCS scores, Short Musculoskeletal Function Assessment (SMFA) function and bother components, and visual analog scale (VAS) pain were collected preoperatively and in the 1 to 2-year follow-up. The Wilcoxon rank sum was used to assess differences in outcomes by depression and low preoperative MCS scores. Multivariable models were then constructed to evaluate between-group differences in change scores according to preoperative SF-36 MCS scores and a diagnosis of depression, with adjustment for baseline patient and treatment characteristics.

Results: Patients with depression and those with low preoperative MCS scores had significantly worse final outcome scores along with reduced improvement in SF-36 PCS and VAS pain scores compared with patients without these risk factors. Among patients with depression, low preoperative MCS scores helped to differentiate patients with poor final outcome scores. Similarly, in patients with low preoperative MCS scores, depression helped to differentiate patients with poor final outcome scores.

Conclusions: Although patients achieved significant improvements in functional outcomes regardless of cohort, decreased preoperative mental health modulated the impact of depression on outcomes. Patients with diminished preoperative mental health and depression are at an increased risk for sustaining smaller improvements in outcomes.

Level Of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.20.00395DOI Listing
January 2021

From Patient to Procedure: The Process of Creating a Custom 3D-Printed Medical Device for Foot and Ankle Pathology.

Foot Ankle Spec 2021 Jun 3;14(3):271-280. Epub 2020 Dec 3.

Department of Orthopaedic Surgery, Duke University Durham, North Carolina.

Three-dimensional (3D) printing technology has advanced greatly over the past decade and is being used extensively throughout the field of medicine. Several orthopaedic surgery specialties have demonstrated that 3D printing technology can improve patient care and physician education. Foot and ankle pathology can be complex as the 3D anatomy can be challenging to appreciate. Deformity can occur in several planes simultaneously and bone defects either from previous surgery or trauma can further complicate surgical correction. Three-dimensional printing technology provides an avenue to tackle the challenges associated with complex foot and ankle pathology. A basic understanding of how these implants are designed and made is important for surgeons as this technology is becoming more widespread and the clinical applications continue to grow within foot and ankle surgery. Level V.
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http://dx.doi.org/10.1177/1938640020971415DOI Listing
June 2021

Clinical applications of custom 3D printed implants in complex lower extremity reconstruction.

3D Print Med 2020 Oct 2;6(1):29. Epub 2020 Oct 2.

Department of Orthopaedic Surgery, Duke University, 4709 Creekstone Drive, Suite 300, Durham, NC, 27703, USA.

Background: Three dimensional printing has greatly advanced over the past decade and has made an impact in several industries. Within the field of orthopaedic surgery, this technology has vastly improved education and advanced patient care by providing innovating tools to complex clinical problems. Anatomic models are frequently used for physician education and preoperative planning, and custom instrumentation can assist in complex surgical cases. Foot and ankle reconstruction is often complicated by multiplanar deformity and bone loss. 3D printing technology offers solutions to these complex cases with customized implants that conform to anatomy and patient specific instrumentation that enables precise deformity correction.

Case Presentation: The authors present four cases of complex lower extremity reconstruction involving segmental bone loss and deformity - failed total ankle arthroplasty, talus avascular necrosis, ballistic trauma, and nonunion of a tibial osteotomy. Traditional operative management is challenging in these cases and there are high complication rates. Each case presents a unique clinical scenario for which 3D printing technology allows for innovative solutions.

Conclusions: 3D printing is becoming more widespread within orthopaedic surgery. This technology provides surgeons with tools to better tackle some of the more challenging clinical cases especially within the field of foot and ankle surgery.
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http://dx.doi.org/10.1186/s41205-020-00083-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531160PMC
October 2020

Total Ankle Total Talus Replacement Using a 3D Printed Talus Component: A Case Report.

J Foot Ankle Surg 2020 Nov - Dec;59(6):1306-1312. Epub 2020 Aug 15.

Assistant Professor, Duke University Medical Center, Durham, NC.

The 3D custom total talus replacement is a novel treatment for avascular necrosis of the talus. However, patients who require a total talus replacement often have concomitant degenerative changes to the tibiotalar, subtalar, or talonavicular joints. The combined 3D custom total ankle-total talus replacement (TATTR) is used for patients with an unreconstructable talus and adjacent tibial plafond involvement. The goal of performing a TATTR is to provide pain relief, retain motion at the tibiotalar joint, maintain or improve the patient's functional status, and minimize limb shortening. TATTR is made possible by 3D printing. The advent of 3D printing has allowed for the accurate recreation of the native talar anatomy with a talar dome that can be matched to a total ankle replacement polyethylene bearing. In this article, we will discuss a case of talar avascular necrosis treated with a combined TATTR and review the current literature for TATTR.
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http://dx.doi.org/10.1053/j.jfas.2020.08.013DOI Listing
June 2021

Comparison of 3D Printed Spherical Implants versus Femoral Head Allografts for Tibiotalocalcaneal Arthrodesis.

J Foot Ankle Surg 2020 Nov - Dec;59(6):1167-1170. Epub 2020 Aug 21.

Professor, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC.

Successful tibiotalocalcaneal (TTC) arthrodesis can be difficult to achieve in patients with bulk bone defects even with the use of femoral head allograft. Retrograde intramedullary nail placement through custom 3-dimensional (3D) spherical implants is an innovative option for these patients. The purpose of this study was to compare fusion rates, graft resorption, and complication rates between patients undergoing TTC fusion with 3D sphere implants versus femoral head allografts. Patients who underwent TTC arthrodesis with an intramedullary nail along with a 3D spherical implant (n = 8) or femoral head allograft (n = 7) were included in this study. The rate of successful fusion of the tibia, calcaneus, and talar neck to the 3D sphere or femoral head allograft was compared between the groups. The rate of total fused articulations was significantly higher in the 3D sphere group (92%) than the femoral head allograft group (62%; p = .018). The number of patients achieving successful fusion of all 3 articulations was higher in the 3D sphere group (75%) than the femoral head allograft group (42.9%, p = .22). The rate of graft resorption was significantly higher in the femoral head allograft group (57.1%) than the 3D sphere group (0%, p = .016). There were no significant differences between the groups in terms of complications. These data demonstrate that the use of a custom 3D printed sphere implant is safe in patients with severe bone loss undergoing TTC arthrodesis with a retrograde intramedullary nail and may result in improved rates of successful arthrodesis.
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http://dx.doi.org/10.1053/j.jfas.2019.10.015DOI Listing
June 2021

Total ankle arthroplasty and ankle arthrodesis in rheumatic disease patients: An analysis of outcomes and complications using the National Inpatient Sample (NIS) database.

Foot Ankle Surg 2021 Apr 22;27(3):321-325. Epub 2020 Jul 22.

Duke University Department of Orthopedic Surgery, United States.

Introduction: Rheumatoid arthritis (RA), can manifest as an inflammatory arthropathy in the ankle. As a result, this study sought to examine the role of RA with respect to complications in patients undergoing either total ankle arthroplasty or ankle arthrodesis by utilizing the National Inpatient Sample to assess for correlations.

Methods: Admissions for TAA and AA were extracted from the National Inpatient Sample using primary ICD-9-CM diagnosis codes. Patients aged 18-65 years with a duration of hospital stay of >3 days and isolated complications were included. Multivariable regression was then performed within matched groups to determine differences.

Results: There was decreased risk of myocardial infarction, pulmonary embolism, surgical site infection, and urinary tract infection in patients with RA. Postoperative development of pneumonia was seen at a higher rate in patients with RA.

Conclusion: RA is not associated with a markedly increased complication burden in the appropriately chosen surgical candidate for ankle arthrodesis and ankle arthroplasty.
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http://dx.doi.org/10.1016/j.fas.2020.07.006DOI Listing
April 2021

Intraoperative Fire Risk: Evaluating the 3-Minute Wait After Chlorhexidine-Alcohol Antiseptic Scrub.

J Orthop Trauma 2021 01;35(1):e31-e33

Duke University Hospital, Durham, NC.

Objective: We sought to determine the flammability of the skin at different time intervals after chlorhexidine-alcohol antiseptic scrub application, to provide evidence for hospital protocols recommending a 3-minute drying time.

Methods: Swine feet, which contain the skin, subcutaneous tissue, muscle, and bone, were used for an experimental cohort. The skin was prepped with chlorhexidine-alcohol solution. Attempted ignition with an open flame was then performed in the presence of visible pooling, as well as at time points 0, 30, 60, and 90 seconds after application, in addition to when the skin appeared visibly dry. Six samples were used for each time point tested.

Results: At time 0 seconds and with gross pooling, ignition was achieved with all samples tested. However, at 30 seconds, only 2 of 6 samples were ignited (which appeared wet). No samples after 60 or 90 seconds were flammable. Samples appeared dry after an average of 40.5 seconds and were not able to ignite.

Conclusions: Although our findings do support that a chlorhexidine-alcohol antiseptic scrub is a potentially flammable surgical prep solution, we found little support for a 3-minute time cutoff. More importantly, the presence of pooling and persistently wet appearing prep is a more important fire risk than the time elapsed after prep application. Caution should be used when working with any flammable solution, and efforts to minimize chemical burns and combustion should be sought based on evidence.
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http://dx.doi.org/10.1097/BOT.0000000000001885DOI Listing
January 2021

Patient Characteristics of Possible Responders and Nonresponders to Total Ankle Arthroplasty.

Foot Ankle Int 2020 08 9;41(8):893-900. Epub 2020 Jun 9.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA.

Background: Characteristics of responders, or those who achieve a clinical improvement above the level of a minimal clinically important difference, have not been defined for total ankle arthroplasty (TAA). The purpose of this study was to determine patient characteristics that distinguish possible responders from possible nonresponders after TAA using criteria established for other arthroplasty surgeries.

Methods: Patients undergoing TAA who were enrolled into a prospective study at a single academic center evaluating patient-reported outcomes were included. Patients were characterized as possible responders if the relative or absolute improvement in their 2-year follow-up Short Musculoskeletal Function Assessment (SMFA) function score was at least 50% or 20, respectively, compared with their preoperative score, consistent with Outcome Measures in Rheumatoid Arthritis Clinical Trials and the Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria. Patient factors were then associated with possible responder or nonresponder status and a multivariable analysis was performed. A total of 491 patients with complete data and 2-year follow-up were included in this study.

Results: Multivariable analysis demonstrated that a higher baseline 36-Item Short-Form Survey (SF-36) mental component summary (MCS) score (OR [95% CI], 1.02 [1.01, 1.04]; = .003), indicating better mental health, was associated with being a possible responder to TAA. The presence of rheumatic disease (OR [95% CI], 0.38 [0.22, 0.67]; = .001) was a significant predictor of being a possible nonresponder.

Conclusion: Our data reveal that a higher baseline SF-36 MCS score was associated with increased improvement in SMFA function scores, while rheumatic disease was associated with worse improvement in SMFA function scores after TAA. Patients with rheumatic disease or poor mental health may not achieve as favorable results after TAA and should be counseled appropriately.

Level Of Evidence: Level III, retrospective comparative study.
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http://dx.doi.org/10.1177/1071100720926123DOI Listing
August 2020

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.

Foot Ankle Surg 2021 Jun 18;27(4):381-388. Epub 2020 May 18.

Duke University Medical Center, Box 2887, Durham, NC 27710, United States.

Background: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants.

Materials And Methods: The US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature.

Results: Among 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion.

Conclusion: Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants.

Level Of Evidence: Level IV; Case Series from Large Database Analysis; Treatment Study.
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http://dx.doi.org/10.1016/j.fas.2020.05.002DOI Listing
June 2021

Arthroscopic Treatment of Osteochondral Lesions of the Talus With Microfracture and Platelet-Rich Plasma-Infused Micronized Cartilage Allograft.

Arthrosc Tech 2020 May 10;9(5):e627-e637. Epub 2020 Apr 10.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina, U.S.A.

Osteochondral lesions of the talus (OLTs) are difficult to treat. Arthroscopic microfracture augmented with micronized cartilage (BioCartilage; Arthrex, Naples, FL) and platelet-rich plasma is emerging as a treatment for moderate-sized, well-contained full-thickness OLTs. This treatment may provide superior histologic results and is less technically demanding and yields less morbidity than an open osteochondral allograft or autograft transfer. This technique guide presents the senior author's preferred strategy for treatment of a moderate-sized OLT with arthroscopic microfracture and placement of micronized cartilage and platelet-rich plasma.
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http://dx.doi.org/10.1016/j.eats.2020.01.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253718PMC
May 2020

Improvement in Health-Related Quality of Life After Total Ankle Arthroplasty Compares Well With Other Successful Orthopaedic and Nonorthopaedic Procedures.

Foot Ankle Spec 2020 May 12:1938640020917782. Epub 2020 May 12.

St Luke's University Health Network, Quakertown, Pennsylvania (JRL).

Ankle arthritis is a major cause of disability. Orthopaedic literature suggests improvement in health-related quality of life (HRQOL) after total ankle arthroplasty (TAA). This has not been compared with improvements observed in successful orthopaedic and nonorthopaedic procedures, including anterior cervical discectomy/fusion (ACDF), total knee arthroplasty (TKA), coronary artery bypass grafting (CABG), and orthotopic liver transplant (OLT). We hypothesize that the effects after TAA are comparable to several successful surgical procedures. 500 consecutive TAA patients were included and grouped with 2 other large series. Short Form-36 (SF36) were collected at standardized intervals. A systematic literature review identified studies comparing preoperative and postoperative SF36 physical (PCS) and mental component summary (MCS) scores. Using meta-analyses, we pooled the data for each procedure to compare with the TAA group. Patients in all cohorts had preoperative SF36 MCS and PCS scores that were significantly lower than that in the general population. Improvements in HRQOL after TAA were not statistically different from improvements reported in PCS and MCS after ACDF, TKA, and OLT. However, improvement in PCS after TAA was better than that observed after CABG. Disability with ankle arthritis is severe. Disability associated with cervical disc disease, knee arthrosis, coronary artery disease, and liver failure is also severe, with surgical intervention providing major improvements in HRQOL postoperatively. The improvement in HRQOL after TAA did not differ statistically from ACDF, TKA, CABG, and OLT. Our investigation suggests that the HRQOL benefits of TAA meet benchmarks set by some of modern medicine's best. Level III: Systematic review.
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http://dx.doi.org/10.1177/1938640020917782DOI Listing
May 2020

Three-Dimensional Printed Cage in Patients With Tibiotalocalcaneal Arthrodesis Using a Retrograde Intramedullary Nail: Early Outcomes.

Foot Ankle Spec 2020 May 11:1938640020920947. Epub 2020 May 11.

Division of Sports Medicine, Department of Orthopaedic Surgery, University of Illinois at Chicago, Illinois (LBP).

. Segmental bone loss in the hindfoot hinders the chance of successful outcomes. Tibiotalocalcaneal arthrodesis is a reliable option; nevertheless, the risk of nonunion is high. Three-dimensional (3D) printed titanium implants offer a strong scaffold that can be customized and has demonstrated encouraging healing rates. In this study, we described the clinical outcomes and the radiologic union rate of a case series of patients with hindfoot arthrodesis, using a retrograde intramedullary nail associated to a 3D printed titanium cage. . Seven patients undergoing hindfoot arthrodesis, using a retrograde intramedullary nail associated to a custom 3D printed titanium cage, were included. Demographic data were collected. Functional outcomes were assessed using the American Orthopedic Foot and Ankle Score and the Visual Analogue Scale for pain. Hindfoot alignment and radiographic union were evaluated using weight-bearing radiographs and computed tomography scan, respectively. . A total of 6 (85%) patients had more than 50% bony bridging. Only 1 patient underwent below knee amputation due to recurrence of chronic osteomyelitis. Two additional patients had minor complications. . Tibiotalocalcaneal arthrodesis using customized titanium cages for patients with large bone defects has shown a high rate of union in those at risk of nonunion. However, further research with larger series is needed. Level IV: Case series.
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http://dx.doi.org/10.1177/1938640020920947DOI Listing
May 2020

Analysis of 408 Total Ankle Arthroplasty Adverse Events Reported to the US Food and Drug Administration From 2015 to 2018.

Foot Ankle Spec 2020 May 8:1938640020919538. Epub 2020 May 8.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina (JC, CCA, RK, MEE, SBA, JKD, JAN).

. Total ankle arthroplasty (TAA) use has increased with newer generation implants. Current reports in the literature regarding complications use data extracted from high-volume centers. The types of complications experienced by lower-volume centers may not be reflected in these reports. The purpose of this study was to determine a comprehensive TAA adverse event profile from a mandatory-reporting regulatory database. . The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2015 to 2018 to determine reported adverse events for approved implants. . Among 408 unique TAA device failures, the most common modes of failure were component loosening (17.9%), intraoperative guide or jig error (15.4%), infection (13.7%), and cyst formation (12.7%). In addition, the percentage distribution of adverse event failure types differed among implants. . The MAUDE database is a publicly available method that requires mandatory reporting of approved device adverse events. Using this report, we found general agreement in types of complications reported in the literature, although there were some differences, as well as differences between implants. These data may more accurately reflect a comprehensive profile of TAA complications as data were taken from a database of all device users rather than only high-volume centers. NA.
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http://dx.doi.org/10.1177/1938640020919538DOI Listing
May 2020

Salvage Arthrodesis for Failed Total Ankle Replacement.

Authors:
Samuel B Adams

Foot Ankle Clin 2020 Jun 24;25(2):281-291. Epub 2020 Mar 24.

Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Medical Center, 4709 Creekstone Drive, Durham, NC 27703, USA. Electronic address:

Salvage arthrodesis for failed total ankle replacement can be a successful procedure. The decision to perform salvage arthrodesis is based on many factors, but the following are the most important indications: severe loss of bonestock (tibia, talus, or both), inadequate soft tissue coverage, or the inability to eradicate an infection. With few revision implants on the market, salvage arthrodesis is currently the most common treatment for failed replacement and justification for revision ankle replacement is limited when any of these factors are present.
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http://dx.doi.org/10.1016/j.fcl.2020.02.003DOI Listing
June 2020

Results of Tibia and Fibula Osteotomies Performed Concomitant to Total Ankle Replacement.

Foot Ankle Int 2020 03 9;41(3):259-266. Epub 2019 Dec 9.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA.

Background: Neutral ankle alignment along with medial and lateral support are paramount to the success of total ankle replacement (TAR). Fibula, intra-articular medial malleolus, and supramalleolar tibia osteotomies have been described to achieve these goals; however, the literature is scant with outcomes and union rates of these osteotomies performed concomitant to TAR. The purpose of this study was to describe our results.

Methods: A retrospective review was performed to identify patients who had a concomitant tibia, fibula, or combined tibia and fibula osteotomy at the same time as TAR. Routine radiographs were used to assess osteotomy union rates and changes in alignment. Outcomes questionnaires were evaluated preoperatively and at most recent follow-up. Twenty-six patients comprising 4% of the total TAR cohort were identified with a mean follow-up of 3.9 years.

Results: There were 12 combined tibia and fibula osteotomies, 9 isolated tibia osteotomies, and 5 isolated fibula osteotomies. The union rate for these osteotomies was 92%, 100%, and 100%, respectively. Mean coronal alignment improved from 15.2 to 2.1 degrees ( < .001). There was significant improvement in patient-reported outcome scores, including Short Form-36, Short Musculoskeletal Function Assessment, and visual analog scale pain. There was 1 failure in the study.

Conclusion: These data demonstrate successful use of tibia, fibula, or combined tibia and fibula osteotomies at the same time as TAR in order to gain neutral ankle alignment. The overall union rate was 96% with significant improvement in alignment, pain, and patient-reported outcomes. We believe concomitant osteotomies can be considered a successful adjunctive procedure to TAR.

Level Of Evidence: Level III, retrospective comparative series.
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http://dx.doi.org/10.1177/1071100719892221DOI Listing
March 2020

Particulated juvenile articular cartilage allograft transplantation for osteochondral lesions of the knee and ankle.

Expert Rev Med Devices 2020 Mar 3;17(3):235-244. Epub 2020 Mar 3.

Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.

: Osteochondral lesions have been challenging to treat due to the limited regenerative capacity of native hyaline cartilage. Although surgical options are available, a newer technique, Particulated Juvenile Cartilage Allograft Transplantation (PJCAT) has shown promise for lesions of the knee and ankle. Short-term studies have been encouraging of its use, but there is still limited evidence of its long-term durability.: This review will summarize the surgical options currently available for osteochondral lesions, outline the indications and contraindications of PJCAT, present the basic science and clinical evidence of the procedure, and describe the surgical approaches of this technique.: PJCAT is a promising method to treat osteochondral lesions. However, continued research is needed to document the efficacy of this technique and potential superiority over other techniques. Benefits include ease of application, potential for arthroscopic or minimally invasive delivery, no need for perpendicular access, no donor site morbidity, and delivery of viable chondrocytes in hyaline cartilage.
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http://dx.doi.org/10.1080/17434440.2020.1733973DOI Listing
March 2020

Systematic Review of Subtalar Distraction Arthrodesis for the Treatment of Subtalar Arthritis.

Foot Ankle Int 2020 04 20;41(4):437-448. Epub 2020 Jan 20.

Department of Orthopaedics, Duke Medical Center, Durham, NC, USA.

Background: Subtalar distraction arthrodesis (SDA) was developed as a means of treating the symptoms of subtalar arthritis. Despite almost 30 years of research in this field, many controversies still exist regarding SDA. The objective of this study was to present an overview of outcomes following SDA, focusing on surgical technique as well as clinical and radiographic results.

Methods: MEDLINE and EMBASE were queried and data abstraction was performed by 2 independent reviewers. Inclusion criteria for the articles were (1) English language, (2) peer-reviewed clinical studies with evidence levels I to IV, (3) with at least 5 patients, and (4) reporting clinical and/or radiographic outcomes of SDA.

Results: Twenty-five studies matched the inclusion criteria (2 Level III and 23 Level IV studies) including 492 feet in 467 patients. The most common indication for SDA was late complications of calcaneus fractures. Many different operative techniques have been described, and there is no proven superiority of one method over the other. The most commonly reported complications were nonunion, hardware prominence, wound complications, and sural neuralgia. All studies showed both radiographic and clinical improvement at the last follow-up visit compared with the preoperative evaluation. Pooled results (12 studies, 237 patients) demonstrated improved American Orthopaedic Foot & Ankle Society ankle-hindfoot scores with a weighted average of 33 points of improvement.

Conclusion: SDA provides good clinical results at short-term and midterm follow-up, with improvement in ankle function as well as acceptable complication and failure rates. Higher quality studies are necessary to better assess outcomes between different operative techniques.

Level Of Evidence: Level III.
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http://dx.doi.org/10.1177/1071100719899050DOI Listing
April 2020

Five-Year Follow-Up of Distal Tibia Bone and Foot and Ankle Trauma Treated with a 3D-Printed Titanium Cage.

Case Rep Orthop 2019 26;2019:7571013. Epub 2019 Nov 26.

Department of Orthopaedic Surgery, Duke University Medical Center, USA.

Large bone defects from trauma or cancer are difficult to treat. Current treatment options include the use of external fixation with bone transport, bone grafting, or amputation. These modes of therapy continue to pose challenges as they are associated with high cost, failure, and complication rates. In this study, we report a successful case of bone defect treatment using personalized 3D-printed implant. This is the longest known follow-up using a 3D-printed custom implant for this specific application. Ultimately, this report adds to existing literature as it demonstrates successful and maintained incorporation of bone into the titanium implant. The use of patient-specific 3D-printed implants adds to the available arsenal to treat complex pathologies of the foot and ankle. Moreover, the technology's flexibility and ease of customization makes it conducive to tailor to specific patient needs.
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http://dx.doi.org/10.1155/2019/7571013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899301PMC
November 2019

Inflammatory cytokines and matrix metalloproteinases in the synovial fluid after intra-articular elbow fracture.

J Shoulder Elbow Surg 2020 Apr 26;29(4):736-742. Epub 2019 Nov 26.

Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA.

Background And Hypothesis: Post-traumatic elbow contracture remains a common and challenging complication with often unsatisfactory outcomes. Although the etiology is unknown, elevated or abnormal post-fracture synovial fluid cytokine levels may result in the migration of fibroblasts to the capsule and contribute to capsular pathology. Thus, the purpose of this study was to characterize the cytokine composition in the synovial fluid fracture hematoma of patients with intra-articular elbow fractures.

Methods: The elbow synovial fluid fracture hematoma of 11 patients with intra-articular elbow fractures was analyzed for CTXII (C-terminal telopeptides of type II collagen [a cartilage breakdown product]) as well as 15 cytokines and matrix metalloproteinases (MMPs) including interferon γ, interleukin (IL) 1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, tumor necrosis factor α, MMP-1, MMP-2, MMP-3, MMP-9, and MMP-10. The uninjured, contralateral elbow served as a matched control. Mean concentrations of each factor were compared between the fluid from fractured elbows and the fluid from control elbows.

Results: The levels of 14 of 15 measured cytokines and MMPs-interferon γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, tumor necrosis factor α, MMP-1, MMP-3, MMP-9, and MMP-10-were significantly higher in the fractured elbows. In addition, post hoc power analysis revealed that 10 of 14 significant differences were detected with greater than 90% power. The mean concentration of CTXII was not significantly different between groups.

Conclusions: These results demonstrate a proinflammatory environment after fracture that may be the catalyst to the development of post-traumatic elbow joint contracture. The cytokines with elevated levels were similar, although not identical, to the cytokines with elevated levels in studies of other weight-bearing joints, indicating the elbow responds uniquely to trauma.
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http://dx.doi.org/10.1016/j.jse.2019.09.024DOI Listing
April 2020

Prospective Randomized Trial Comparing Mobile-Bearing and Fixed-Bearing Total Ankle Replacement.

Foot Ankle Int 2019 Nov 27;40(11):1239-1248. Epub 2019 Sep 27.

Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Health System, Durham, NC, USA.

Background: Outcomes of total ankle replacement for the treatment of end-stage ankle arthritis continue to improve. Debate continues whether a mobile-bearing total ankle replacement (MB-TAR) or a fixed-bearing total ankle replacement (FB-TAR) is superior, with successful outcomes reported long term for MB-TAR and at intermediate- to long-term follow-up for newer generation FB-TAR. Although comparisons between the 2 total ankle designs have been reported, to our knowledge, no investigation has compared the 2 designs with a high level of evidence. This prospective, randomized controlled trial conducted at a single institution compares patient satisfaction, functional outcomes, and radiographic results of the mobile-bearing STAR and the fixed-bearing Salto-Talaris in the treatment of end-stage ankle arthritis.

Methods: Between November 2011 and November 2014, adult patients with end-stage ankle osteoarthritis failing nonoperative treatment were introduced to the study. With informed consent, 100 patients (31 male and 69 female, average age 65 years, range 35-85 years) were enrolled; a demographic comparison between the 2 cohorts was similar. Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees, or extensive talar dome wear pattern ("flat-top talus"). Prospective patient-reported outcomes, physical examination, and standardized weightbearing ankle radiographs were obtained preoperatively, at 6 and 12 months postoperatively, and then at yearly intervals. Data collection included visual analog pain score, Short Form 36, Foot and Ankle Disability Index, Short Musculoskeletal Functional Assessment, and American Orthopaedic Foot & Ankle Society ankle-hindfoot score. Surgeries were performed by a nondesign team of orthopedic foot and ankle specialists with total ankle replacement expertise. Statistical analysis was performed by a qualified statistician. At average follow-up of 4.5 years (range, 2-6 years) complete clinical data and radiographs were available for 84 patients; 7 had incomplete data, 1 had died, 4 were withdrawn after enrolling but prior to surgery, and 4 were lost to follow-up.

Results: In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up with no statistically significant difference between the 2 groups. Radiographically, tibial lucency/cyst formation was 26.8% and 20.9% for MB-TAR and FB-TAR, respectively. Tibial settling/subsidence occurred in 7.3% of MB-TAR. Talar lucency/cyst formation occurred in 24.3% and 2.0% of MB-TAR and FB-TAR, respectively. Talar subsidence was observed in 21.9% and 2.0% of MB-TAR and FH-TAR, respectively. Reoperations were performed in 8 MB-TARs and 3 FH-TARs, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants.

Conclusion: With a high level of evidence, our study found that patient-reported and clinical outcomes were favorable for both designs and that there was no significant difference in clinical improvement between the 2 implants. The incidence of lucency/cyst formation was similar for MB-TAR and FH-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence. As has been suggested in previous studies, clinical outcomes do not necessarily correlate with radiographic findings. Reoperations were more common for MB-TAR and, in most cases, were to relieve impingement or treat cysts rather than revise or remove metal implants.

Level Of Evidence: Level I, prospective randomized study.
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http://dx.doi.org/10.1177/1071100719879680DOI Listing
November 2019

Pathogenesis of Posttraumatic Osteoarthritis of the Ankle.

Orthop Clin North Am 2019 Oct;50(4):529-537

Department of Orthopedic Surgery, Duke University Medical Center, 4709 Creekstone Drive, Durham, NC 27703, USA. Electronic address:

Ankle osteoarthritis affects a significant portion of the global adult population. Unlike other joints, arthritis of the ankle often develops as a response to traumatic injury (intra-articular fracture) of the ankle joints. The full mechanism leading to posttraumatic osteoarthritis of the ankle (PTOAA) is poorly understood. These deficits in knowledge pose challenges in the management of the disease. Adequate surgical reduction of fractured ankle joints remains the gold standard in prevention. The purpose of this review is to thoroughly delineate the known pathogenesis of PTOAA, and provide critical updates on this pathology and new avenues to provide therapeutic management of the disease.
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http://dx.doi.org/10.1016/j.ocl.2019.05.008DOI Listing
October 2019
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