Publications by authors named "Peter Verdonk"

108 Publications

Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis: Early Outcomes of a Consecutive Case Series.

J Clin Med 2021 May 21;10(11). Epub 2021 May 21.

MoRe Institute, 2100 Antwerp, Belgium.

The study aimed to evaluate the short-term clinical effect, therapeutic response rate (TRR%), and therapy safety of a single intra-articular autologous MFAT injection for symptomatic knee OA. Secondly, patient- and pathology-related parameters were investigated to tighten patient selection for MFAT therapy. Sixty-four subjects with symptomatic mild-severe knee OA were enrolled in a single-center trial and received a unilateral ( = 37) or bilateral ( = 27) MFAT injection. After liposuction, the adipose tissue was mechanically processed with the Lipogem device, which eventually produced 8-10 cc of MFAT. Subjects were clinically assessed by means of the KOOS, NRS, UCLA, and EQ-5D at baseline and 1, 3, 6, and 12 months after injection. Adverse events were recorded at each follow-up timepoint. The TRR was defined according to the OMERACT-OARSI criteria and baseline MRI was scored following the MOAKS classification. The TRR of the index knee was 64% at 3 months and 45% at 12 months after injection. Therapy responders at 12 months improved with 28.3 ± 11.4 on KOOS pain, while non-responders lost -2.1 ± 11.2 points. All clinical scores, except the UCLA, improved significantly at follow-up compared to baseline ( < 0.05). In the bilateral cohort, no difference in baseline scores or TRR was found between the index knee and contralateral knee (n.s.). An inflammatory reaction was reported in 79% of knees and resolved spontaneously within 16.6 ± 13.5 days after MFAT administration. Numerous bone marrow lesions (BML) were negatively correlated with the TRR at 12 months ( = 0.003). The study demonstrated an early clinical improvement but a mediocre response rate of 45% at 12 months after a single intra-articular injection with autologous MFAT. Assessment of bone marrow lesions on MRI can be helpful to increase the therapeutic responsiveness of MFAT up to 70% at 12 months. In comparison to repetitive injection therapies such as cortisone, hyaluronic acid, and PRP, administration of MFAT might become a relevant alternative in well-selected patients with symptomatic knee OA.
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http://dx.doi.org/10.3390/jcm10112231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196751PMC
May 2021

Human meniscus allograft augmentation by allogeneic mesenchymal stromal/stem cell injections.

J Orthop Res 2021 May 10. Epub 2021 May 10.

Orthopedics and Sports Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Meniscus allograft transplantations (MATs) represent established surgical procedures with proven outcomes. Yet, storage as frozen specimens and limited cellular repopulation may impair graft viability. This proof-of-concept study tests the feasibility of injecting allogeneic mesenchymal stromal/stem cells (MSCs) in meniscus allograft tissue. We investigated the injectable cell quantity, survival rate, migration, and proliferation ability of MSCs up to 28 days of incubation. In this controlled laboratory study, seven fresh-frozen human allografts were injected with human allogeneic MSCs. Cells were labeled and histological characteristics were microscopically imaged up to 28 days. Mock-injected menisci were included as negative controls in each experiment. Toluidine blue staining demonstrated that a 100-µl volume can be injected while retracting and rotating the inserted needle. Immediately after injection, labeled MSCs were distributed throughout the injection channel and eventually migrated into the surrounding tissues. Histological assessment revealed that MSCs cluster in disc-like shapes, parallel to the intrinsic lamination of the meniscus and around the vascular network. Quantification showed that more than 60% of cells were present in horizontally injected grafts and more than 30% were observed in vertically injected samples. On Day 14, cells adopted a spindle-shaped morphology and exhibited proliferative and migratory behaviors. On Day 28, live/dead ratio assessment revealed an approximately 80% cell survival. The study demonstrated the feasibility of injecting doses of MSCs (>0.1 million) in meniscus allograft tissue with active cell proliferation, migration, and robust cell survival.
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http://dx.doi.org/10.1002/jor.25074DOI Listing
May 2021

Association of Ligamentous Laxity, Male Sex, Chronicity, Meniscal Injury, and Posterior Tibial Slope With a High-Grade Preoperative Pivot Shift: A Post Hoc Analysis of the STABILITY Study.

Orthop J Sports Med 2021 Apr 6;9(4):23259671211000038. Epub 2021 Apr 6.

Investigation performed at the Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Background: A spectrum of anterolateral rotatory laxity exists in anterior cruciate ligament (ACL)-injured knees. Understanding of the factors contributing to a high-grade pivot shift continues to be refined.

Purpose: To investigate factors associated with a high-grade preoperative pivot shift and to evaluate the relationship between this condition and baseline patient-reported outcome measures (PROMs).

Study Design: Cross-sectional study; Level of evidence, 3.

Methods: A post hoc analysis was performed of 618 patients with ACL deficiency deemed high risk for reinjury. A binary logistic regression model was developed, with high-grade pivot shift as the dependent variable. Age, sex, Beighton score, chronicity of the ACL injury, posterior third medial or lateral meniscal injury, and tibial slope were selected as independent variables. The importance of knee hyperextension as a component of the Beighton score was assessed using receiver operator characteristic curves. Baseline PROMs were compared between patients with and without a high-grade pivot.

Results: Six factors were associated with a high-grade pivot shift: Beighton score (each additional point; odds ratio [OR], 1.17; 95% CI, 1.06-1.30; = .002), male sex (OR, 2.30; 95% CI, 1.28-4.13; = .005), presence of a posterior third medial (OR, 2.55; 95% CI, 1.11-5.84; = .03) or lateral (OR, 1.76; 95% CI, 1.01-3.08; = .048) meniscal injury, tibial slope >9° (OR, 2.35; 95% CI, 1.09-5.07; = .03), and chronicity >6 months (OR, 1.70; 95% CI, 1.00-2.88; = .049). The presence of knee hyperextension improved the diagnostic utility of the Beighton score as a predictor of a high-grade pivot shift. Tibial slope <9° was associated with only a high-grade pivot in the presence of a posterior third medial meniscal injury. Patients with a high-grade pivot shift had higher baseline 4-Item Pain Intensity Measure scores than did those without a high-grade pivot shift (mean ± SD, 11 ± 13 vs 8 ± 14; = .04); however, there was no difference between groups in baseline International Knee Documentation Committee, ACL Quality of Life, Knee injury and Osteoarthritis Outcome Score, or Knee injury and Osteoarthritis Outcome Score subscale scores.

Conclusion: Ligamentous laxity, male sex, posterior third medial or lateral meniscal injury, increased posterior tibial slope, and chronicity were associated with a high-grade pivot shift in this population deemed high risk for repeat ACL injury. The effect of tibial slope may be accentuated by the presence of meniscal injury, supporting the need for meniscal preservation. Baseline PROMs were similar between patients with and without a high-grade pivot shift.
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http://dx.doi.org/10.1177/23259671211000038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8033400PMC
April 2021

Aragonite-Based Scaffold for the Treatment of Joint Surface Lesions in Mild to Moderate Osteoarthritic Knees: Results of a 2-Year Multicenter Prospective Study.

Am J Sports Med 2021 03 22;49(3):588-598. Epub 2021 Jan 22.

Orthopedic Research Unit and Foot and Ankle Service, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel.

Background: Osteoarthritis (OA) is considered a contraindication to most cartilage repair techniques. Several regenerative approaches have been attempted with the aim of delaying or preventing joint replacement, with controversial results. Currently, there is a paucity of data on the use of single-step techniques, such as cell-free biomimetic scaffolds, for the treatment of joint surface lesions (JSLs) in OA knees.

Purpose: To present the 2-year follow-up clinical and radiological outcomes after implantation of a novel, cell-free aragonite-based scaffold for the treatment of JSLs in patients with mild to moderate knee OA in a multicenter prospective study.

Study Design: Case series; Level of evidence, 4.

Methods: A total of 86 patients, 60 male and 26 female, with a mean age of 37.4 ± 10.0 years, mild to moderate knee OA, and a mean defect size of 3.0 ± 1.7 cm, were recruited at 8 medical centers according to the following criteria: radiographic mild to moderate knee OA (Kellgren-Lawrence grade 2 or 3); up to 3 treatable chondral/osteochondral defects (International Cartilage Repair Society grades 3 and 4) on the femoral condyles or trochlea; a total defect size ≤7 cm; and no concurrent knee instability, severe axial malalignment, or systemic arthropathy. All patients were evaluated at baseline and at 6, 12, 18, and 24 months after implantation using the Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) subjective score. Additionally, magnetic resonance imaging (MRI) was performed to assess the amount of cartilage defect filling at the repaired site.

Results: Significant improvement on all KOOS subscales was recorded from baseline (Pain: 49.6 ± 13.1; Activities of Daily Living [ADL]: 56.1 ± 18.4; Sport: 22.8 ± 18.8; Quality of Life [QoL]: 23.5 ± 16.5; Symptoms: 55.4 ± 19.9) to the 24 months' follow-up (Pain: 79.5 ± 21.1 [ < .001]; ADL: 84.1 ± 21.4 [ < .001]; Sport: 60.8 ± 31.9 [ < .001]; QoL: 54.9 ± 30.4 [ < .001]; Symptoms: 77.7 ± 21.2 [ < .001]). The IKDC subjective score showed a similar trend and improved from 37.8 ± 14.7 at baseline to 65.8 ± 23.5 at 24 months ( < .001). MRI showed a significant increase in defect filling over time: up to 78.7% ± 25.3% of surface coverage after 24 months. Treatment failure requiring revision surgery occurred in 8 patients (9.3%).

Conclusion: The use of an aragonite-based osteochondral scaffold in patients with JSLs and mild to moderate knee OA provided significant clinical improvement at the 24-month follow-up, as reported by the patients. These findings were associated with good cartilage defect filling, as observed on MRI.
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http://dx.doi.org/10.1177/0363546520981750DOI Listing
March 2021

Joint Surface Lesions in the Knee Treated with an Acellular Aragonite-Based Scaffold: A 3-Year Follow-Up Case Series.

Cartilage 2021 Jan 15:1947603520988164. Epub 2021 Jan 15.

MoRe Foundation, Antwerp, Belgium.

Objective: The study aimed to evaluate the clinical outcome and repair capacity of a cell-free aragonite-based scaffold in patients with an isolated symptomatic joint surface lesion (JSL) of the knee.

Design: Thirteen patients (age 33.5 ± 8.9; female 23%; body mass index 25.3 ± 3.4, K/L [Kellgren-Lawrence] 1.8) with a JSL (2.6 ± 1.7 cm [1.0-7.5 cm]) of the distal femur were enrolled in a single-center prospective case series. Safety and clinical outcome was assessed by the KOOS (Knee Injury and Osteoarthritis Outcome Score), IKDC (International Knee Documentation Committee), Lysholm, and Tegner activity scale at baseline and 6, 12, 18, 24, and 36 months follow-up. The MOCART 2.0 and scaffold integration were evaluated on magnetic resonance imaging at 12, 24, and 36 months postoperatively.

Results: Primary outcome (KOOS pain) improved with 36.5 ± 14.7 points at 12 months ( = 0.002) and 41.2 ± 14.7 points at 36 months ( = 0.002) follow-up. Similar increasing trends were observed for the other KOOS subscales, IKDC, and Lysholm score, which were significantly better at each follow-up time point relative to baseline ( < 0.05). Activity level increased from 2.75 ± 1.6 to 4.6 ± 2.2 points at final follow-up ( = 0.07). The MOCART was 61.7 ± 12.6 at 12 months and 72.9 ± 13.0 at 36 months postoperatively. Sixty-six to 100% implant integration and remodeling was observed in 73.3% cases at 36 months. No serious adverse events were reported.

Conclusion: The study demonstrated that the biphasic aragonite-based scaffold is a safe and clinically effective implant for treating small-medium sized JSLs of the distal femur in a young and active patient cohort. The implant showed satisfying osteointegration and restoration of the osteochondral unit up to 3 years postimplantation.
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http://dx.doi.org/10.1177/1947603520988164DOI Listing
January 2021

Complex Osteochondral Lesions of the Talus Treated With a Novel Bi-Phasic Aragonite-based Implant.

J Foot Ankle Surg 2021 Mar-Apr;60(2):391-395. Epub 2020 Sep 5.

Consultant Orthopedic Surgeon, Humanitas Clinical and Research Center -- IRCCS, Milano, Italy; Associate Professor, Department of Biomedical Sciences, Humanitas University, Milano, Italy; Associate Professor, Department of Traumatology, Orthopedics and Disaster Surgery, Sechenov First Moscow State Medical University, Moscow, Russia.

To present initial results of a novel, bi-phasic, porous, biodegrade, and cell-free aragonite-based scaffold for treating complex osteochondral lesions of the talus (OLT). Four subjects (2 males and 2 females; 34-61 years old) were operated on their ankles due to chronic and deep OLT-Hepple grades 4 or 5 (1.8-2.2 cm). Three subjects had OLT on the medial central trochlea, and 1 had a combined medial and lateral lesions. OLT were exposed through medial malleolus osteotomy, with an additional lateral arthrotomy in the combined lesions. Bi-phasic porous osteochondral scaffolds (single implant or 2 implants) were implanted in a press-fit manner using a designated surgical toolset. Treatment outcome was followed clinically (Foot and Ankle Outcome Score, EQ-5D 3L, Tegner activity scale) and by medical imaging (radiographs, magnetic resonance imaging) from 18 to 32 months. All Foot and Ankle Outcome Score values increased from preoperative to final follow-up values (Symptoms 62 to 71, Pain 53 to 84, ADL 60 to 89, Sport 19 to 65, and QoL 18 to 47). EQ-5D 3L increased from 0.59 to 0.76, and Tegner activity values increased from 1.5 to 3. Kellgren-Lawrence ankle radiographic scores remained stable (2 to 2). Postoperative MR evaluation demonstrated cartilage defect fill of 75% to 100% respect to the native cartilage in 3 subjects (4 OLTs), while 1 lesion was filled 25% to 50%. No graft related serious adverse events or graft failures were reported. The use of a bi-phasic osteochondral biodegradable aragonite-based scaffold in the treatment of complex OLT during the reported period presented positive and promising clinical and radiologic outcome, without serious adverse events or graft failures.
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http://dx.doi.org/10.1053/j.jfas.2020.06.028DOI Listing
September 2020

Patient-specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years.

Knee Surg Sports Traumatol Arthrosc 2020 Oct 6. Epub 2020 Oct 6.

Deptartment of Orthopedics, Aarhus University Hospital, Palle Juul Jensens Boulevard 99, 8200, Århus, Denmark.

Purpose: Surgical treatment options for the management of focal chondral and osteochondral lesions in the knee include biological solutions and focal metal implants. A treatment gap exists for patients with lesions not suitable for arthroplasty or biologic repair or who have failed prior cartilage repair surgery. This study reports on the early clinical and functional outcomes in patients undergoing treatment with an individualised mini-metal implant for an isolated focal chondral defect in the knee.

Methods: Open-label, multicentre, non-randomised, non-comparative retrospective observational analysis of prospectively collected clinical data in a consecutive series of 80 patients undergoing knee reconstruction with the Episealer® implant. Knee injury and Osteoarthritis Outcome Score (KOOS) and VAS scores, were recorded preoperatively and at 3 months, 1 year, and 2 years postoperatively.

Results: Seventy-five patients were evaluated at a minimum 24 months following implantation. Two patients had undergone revision (2.5%), 1 declined participation, and 2 had not completed the full data requirements, leaving 75 of the 80 with complete data for analysis. All 5 KOOS domain mean scores were significantly improved at 1 and 2 years (p < 0.001-0.002). Mean preoperative aggregated KOOS4 of 35 (95% CI 33.5-37.5) improved to 57 (95% CI 54.5-60.2) and 59 (95% CI 55.7-61.6) at 12 and 24 months respectively (p < 0.05). Mean VAS score improved from 63 (95% CI 56.0-68.1) preoperatively to 32 (95% CI 24.4-38.3) at 24 months. The improvement exceeded the minimal clinically important difference (MCID) and this improvement was maintained over time. Location of defect and history of previous cartilage repair did not significantly affect the outcome (p > 0.05).

Conclusion: The study suggests that at 2 years, Episealer® implants are safe with a low failure rate of 2.5% and result in clinically significant improvement. Individualised mini-metal implants with appropriate accurate guides for implantation appear to have a place in the management of focal femoral chondral and osteochondral defects in the knee.

Level Of Evidence: IV.
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http://dx.doi.org/10.1007/s00167-020-06289-7DOI Listing
October 2020

Autologous Protein Solution Injections for the Treatment of Knee Osteoarthritis: 3-Year Results.

Am J Sports Med 2020 09;48(11):2703-2710

Applied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: Blood derivative injections have been recently proposed to address osteoarthritis (OA) with overall positive results, although long-term data on their efficacy are lacking. A novel blood derivative has been developed to concentrate growth factors and antagonists of inflammatory cytokines and shown promising early findings.

Purpose: To investigate if the positive effects of a single intra-articular injection of autologous protein solution (APS) in patients affected by knee OA-previously documented at 1 year in a multicenter double-blind randomized saline-controlled trial-last up to 3 years.

Study Design: Case series; Level of evidence, 4.

Methods: A total of 46 patients with Kellgren-Lawrence 2 or 3 knee OA were randomized into 2 groups: 1 ultrasound-guided APS injection (n = 31) or 1 saline injection (n = 15). At 1 year, the saline group was allowed to cross over. Patients were re-evaluated at 24 and 36 months through the visual analog scale for pain (VAS), Western Ontario and McMaster Universities Osteoarthritis Index Likert 3.1 (WOMAC LK 3.1), Knee injury and Osteoarthritis Outcome Score (KOOS), 36-Item Short Form Health Survey (SF-36), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Magnetic resonance imaging evaluation was performed with the MRI Osteoarthritis Knee Score (MOAKS) before and at 24 months after treatment, and radiographs were assessed per Kellgren-Lawrence before and annually after treatment.

Results: In the APS cohort, WOMAC pain improved from 11.5 ± 2.4 (mean ± SD) to 4.3 ± 4.0 at 1 year and to 5.7 ± 5.0 at 3 years ( < .0001 vs baseline). The APS cohort also showed a statistically significant improvement in its KOOS pain score from 39.4 ± 13.1 to 70.6 ± 21.5 at 1 year and to 64.1 ± 24.6 at 3 years ( < .0001 vs baseline) and VAS pain scores from 5.5 ± 2.2 to 2.6 ± 2.5 at 1 year and to 3.4 ± 2.9 at 3 years ( = .0184 vs baseline). VAS pain score significantly worsened from 12 to 36 months ( = .0411). All patients in the saline group decided to cross over to APS, and their final scores were better than baseline, although not significantly better than at the crossover point. Overall, 7 of 26 (26.9%) APS cases and 4 of 14 (28.6%) crossover cases were considered failures as patients underwent further injective treatments or surgical procedures between the 12- and 36-month follow-up. MOAKS findings showed no statistically significant differences. Patients with better cartilage had greater WOMAC pain improvement when their baseline scores were worse, whereas the trend was reversed for patients with cartilage loss at baseline.

Conclusion: Intra-articular use of APS for mild to moderate knee OA was safe, and significant pain improvement was documented 3 years after a single injection. Patients with better cartilage status seem to respond better than patients with more cartilage loss, with more clinical improvement even when starting from more painful conditions.

Registration: NCT02138890 (ClinicalTrials.gov identifier).
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http://dx.doi.org/10.1177/0363546520944891DOI Listing
September 2020

Small medial femoral condyle morphotype is associated with medial compartment degeneration and distinct morphological characteristics: a comparative pilot study.

Knee Surg Sports Traumatol Arthrosc 2021 Jun 14;29(6):1777-1789. Epub 2020 Aug 14.

Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.

Purpose: Early-onset degeneration of the knee is linked to genetics, overload, injury, and potentially, knee morphology. The purpose of this study is to explore the characteristics of the small medial femoral condyle, as a distinct knee morphotype, by means of a landmark-based three-dimensional (3D) analysis and statistical parametric mapping.

Methods: Sixteen knees with a small medial femoral condyle (SMC) were selected from a database of patients with distinct knee joint anatomy and 16 gender-matched knees were selected from a control group database. 3D models were generated from the medical imaging. After normalization for size, a set of pre-defined landmark-based parameters was analysed for the femur and tibia. Local shape differences were evaluated by matching all bone surfaces onto each other and comparing the distances to the mean control group bone shape.

Results: The small medial condyle group showed a significant association with medial compartment degeneration and had a 4% and 13% smaller medial condyle anteroposteriorly and mediolaterally, whereas the distal femur was 3% wider mediolaterally. The lateral condyle was 2% smaller anteroposteriorly and 8% wider mediolaterally. The complete tibial plateau was 3% smaller mediolaterally and the medial tibial plateau was 6% smaller.

Conclusion: A new knee morphotype demonstrated an increased risk for medial compartment degeneration and was differentiated from a healthy control group based on the following morphological characteristics: a smaller medial femoral condyle and medial tibial plateau, a wider lateral femoral condyle and a wider distal femur on a smaller tibial plateau. This pilot study suggests a role for the SMC knee morphotype in the multifactorial process of medial compartment degeneration.

Level Of Evidence: III.
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http://dx.doi.org/10.1007/s00167-020-06218-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126545PMC
June 2021

Diffusion tensor imaging of the anterior cruciate ligament graft following reconstruction: a longitudinal study.

Eur Radiol 2020 Dec 14;30(12):6673-6684. Epub 2020 Jul 14.

Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.

Objective: To longitudinally monitor remodeling of human autograft following anterior cruciate ligament (ACL) reconstruction with DTI.

Methods: Twenty-eight patients underwent DTI follow-up at 3, 8, and 14 months after clinically successful ACL reconstruction with tendon autograft. Among these, 18 patients had a concomitant lateral extra-articular procedure (LET). DTI data from 7 healthy volunteers was also obtained. Diffusion parameters (fractional anisotropy, FA; mean diffusivity, MD; axial diffusivity, AD; and radial diffusivity, RD) were evaluated within the fiber tractography volumes of the ACL graft and posterior cruciate ligament (PCL) in all patients. Data were analyzed using a linear mixed-effects model with post hoc testing using Bonferroni-Holm correction for multiple testing. The effect of additional LET was studied.

Results: The ACL graft showed a significant decrease of FA over time (F = 4.00, p = 0.025), while the diffusivities did not significantly change over time. For PCL there were no significant DTI changes over time. A different evolution over time between patients with and without LET was noted for all diffusivity values of the ACL graft with reduced AD values in patients with LET at 8 months postoperatively (p = 0.048; adjusted p = 0.387). DTI metrics of the ACL graft differed largely from both native ACL and tendon at 14 months postoperatively.

Conclusion: Our study has shown the potential of DTI to longitudinally monitor the remodeling process in human ACL reconstruction. DTI analysis indicates that graft remodeling is incomplete at 14 months postoperatively.

Key Points: • DTI can be used to longitudinally monitor the remodeling process in human ACL reconstruction. • DTI analysis indicates that autograft remodeling is incomplete at 14 months postoperatively. • DTI may be helpful for evaluating new ACL treatments.
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http://dx.doi.org/10.1007/s00330-020-07051-wDOI Listing
December 2020

Autologous protein solution as selective treatment for advanced patellofemoral osteoarthritis in the middle-aged female patient: 54% response rate at 1 year follow-up.

Knee Surg Sports Traumatol Arthrosc 2021 Mar 25;29(3):988-997. Epub 2020 May 25.

MoRe Foundation, Antwerp, Belgium.

Purpose: The study wanted to investigate the benefit, durability and safety of autologous protein solution (APS) injection(s) in a middle-aged female-only cohort suffering predominantly from patellofemoral osteoarthritis.

Methods: Fifty females (aged 50.4 ± 6.5) with mainly moderate-severe (86%) patellofemoral cartilage wear (PFCW) were treated with a unilateral intra-articular APS injection. The KOOS, NRS, Kujala, UCLA and EQ-5D were assessed at baseline and 1, 3, 6, and 12 months post-injection. Therapeutic response rate (TRR) was based on KOOS pain improvement > 10 points. Absolute improvement for, respectively, therapy responders and non-responders was determined. Second APS injection was administered if improvement was deemed insufficient by the patient after 3 months.

Results: The TRR remained stable averaging to 53.7% at final follow-up with subjects improving overall from 40.3 ± 18.7 to 57.3 ± 24.8 points on KOOS pain (p = 0.0002) and from 48.4 ± 13.0 to 56.3 ± 18.1 points on Kujala (p = 0.0203) at 12 months. Significant improvement was observed for the other KOOS subscales and NRS at each follow-up. In absolute values, APS responders improved with 30.5 ± 11.4 points on KOOS pain at 12 months. In contrast, non-responders deteriorated with 5.9 ± 8.9 points relative to baseline. A second APS injection was administered in 28 subjects. Patients with definite synovitis improved more on KOOS symptoms (p = 0.017) and KOOS ADL (p = 0.037) at 12 months compared to non-synovitis subjects. Mild-moderate arthralgia (46%) and effusion (29%) were commonly observed during the first month post-injection.

Conclusion: This study evidenced a 54% response rate at 12 months to a single or second APS injection in a middle-aged female population with advanced patellofemoral cartilage wear. Moderate temporary flares can be expected without affecting clinical outcomes. Second APS injection has low efficacy in initially poor responding patients after 3 months. Major synovitis on baseline MRI appeared to be a beneficial prognosticator for pain relief and functional improvement after APS.

Level Of Evidence: IV.
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http://dx.doi.org/10.1007/s00167-020-06064-8DOI Listing
March 2021

Feasibility and 3D Planning of a Novel Patient-Specific Instrumentation Technique in Medial Opening-Wedge High Tibial Osteotomy.

J Knee Surg 2020 May 22. Epub 2020 May 22.

Faculty of Medicine, Antwerp University, Antwerp, Belgium.

A novel approach for opening-wedge high tibial osteotomy (OWHTO) with patient-specific instrumentation (PSI) was evaluated for its safety, feasibility, and accuracy. Next, the mechanical medial proximal tibial angle (mMPTA) was assessed as a potential planning angle by investigating the relation with the mechanical femorotibial angle (mFTA). Ten OWHTO cases were 3D planned using the mMPTA and operated with a customized 3D-printed wedge and cast which resembled the intended osteotomy opening. Patients were closely monitored for intraoperative and postoperative complications up to 1 year after surgery. Radiological assessment was conducted on full leg standing radiographs and supine lower limb computed tomography-scans preoperatively and 3 months after surgery. No intraoperative complications or logistical issues during PSI processing were observed. Absolute accuracy outcomes showed a correction error of 1.3° ± 1.1 mMPTA and 0.9° ± 0.6 mFTA with all osteotomies falling in (-2°; + 2°) mFTA around the target. The mMPTA and mFTA were found to have a strong correlation in both 3D ( = 0.842,  = 0.002) and 2D ( = 0.766,  = 0.01) imaging for effective correction. The study confirmed the development of a safe and feasible PSI technique in OWHTO with excellent accuracy outcomes. The strong correlation between the mMPTA and mFTA indicated that soft tissue changes after OWHTO are of minor significance to the final alignment in ligament-stable patients. Finally, the mMPTA was found to be a reliable planning angle in 3D software for obtaining the intended lower limb realignment and its use can therefore be recommended in modern OWHTO planning.
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http://dx.doi.org/10.1055/s-0040-1710379DOI Listing
May 2020

Returning to orthopaedic business as usual after COVID-19: strategies and options.

Knee Surg Sports Traumatol Arthrosc 2020 Jun 27;28(6):1699-1704. Epub 2020 Apr 27.

Orthoca, Antwerp, Belgium.

Purpose: The aim of this manuscript is to review the available strategies in the international literature to efficiently and safely return to both normal orthopaedic surgical activities and to normal outpatient clinical activities in the aftermath of a large epidemic or pandemic. This information would be beneficial to adequately reorganize outpatient clinics and hospitals to provide the highest possible level of orthopaedic care to our patients in a safe and efficient manner.

Methods: A literature search was performed for relevant research articles. In addition, the World Health Organisation (WHO), the US Centers for Disease Control (CDC), American Association of Orthopaedic Surgeons (AAOS), the EU CDC and other government health agency websites were searched for any relevant information. In particular, interest was paid to strategies and advise on managing the orthopaedic patient flow during outpatient clinics as well as surgical procedures including the necessary safety measures, while still providing a high-quality patient experience. The obtained information is provided as a narrative review.

Results: There was not any specific literature concerning the organization of an outpatient clinic and surgical activities and the particular challenges in dealing with a high-volume practice, in the afterwave of a pandemic.

Conclusion: As the COVID-19 crisis has abruptly halted most of the orthopaedic activities both in the outpatient clinic and the operating room, a progressive start-up scenario needs to be planned. The exact timing largely depends on factors outside of our control. After restrictions will be lifted, clinical and surgical volume will progressively increase. This paper offers key points and possible strategies to provide the highest level of safety to both the orthopaedic patient and the orthopaedic team including administrative staff and nurses, during the start-up phase.

Level Of Evidence: Review, Level V.
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http://dx.doi.org/10.1007/s00167-020-06031-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7185264PMC
June 2020

Polyurethane Meniscal Scaffold for the Treatment of Partial Meniscal Deficiency: 5-Year Follow-up Outcomes: A European Multicentric Study.

Am J Sports Med 2020 May 8;48(6):1347-1355. Epub 2020 Apr 8.

Investigation performed at the Orthopedic Department, Centre Hospitalier de Versailles, Le Chesnay, France.

Background: A biodegradable polyurethane scaffold was developed to treat patients with the challenging clinical condition of painful partial meniscal defects.

Hypothesis: The use of an acellular polyurethane scaffold in patients with symptomatic partial meniscal defects would result in both midterm pain relief and improved function.

Study Design: Case series; Level of evidence, 4.

Methods: A total of 155 patients with symptomatic partial meniscal defects (101 medial and 54 lateral) were implanted with a polyurethane scaffold in a prospective, single-arm, multicentric study with a minimum 5-year follow-up. Clinical outcomes were measured with the visual analog scale for pain, International Knee Documentation Committee subjective knee evaluation form, Lysholm knee scale, and Knee injury and Osteoarthritis Outcome Score at baseline and at 2- and 5-year follow-ups. Magnetic resonance imaging (MRI) was used to evaluate the knee joint, meniscal implant, and meniscal extrusion. Kaplan-Meier survival analysis was also performed. Removal of the scaffold, conversion to a meniscal transplant, and unicompartmental/total knee arthroplasty were used as endpoints.

Results: Eighteen patients were lost to follow-up (11.6%). The patients who were included in this study showed significant clinical improvement after surgery as indicated by the different outcome measures ( = .01). However, the clinical improvement tended to stabilize between 2 and 5 years of follow-up. MRI scans of the scaffolds in 56 patients showed a smaller-sized implant in the majority of the cases when compared with the native meniscus with an irregular surface at the 5-year follow-up. During the follow-up period, 87.6% of the implants survived in this study. At 5 years of follow-up, 87.9% of the medial scaffolds were still functioning versus 86.9% of the lateral scaffolds. In total, 23 treatments had failed: 10 removed scaffolds because of breakage, 7 conversions to meniscal allograft transplantation, 4 conversions to unicompartmental knee arthroplasty, and 2 conversions to total knee arthroplasty.

Conclusion: The polyurethane meniscal implant was able to improve knee joint function and reduce pain in patients with segmental meniscal deficiency over 5 years after implantation. The MRI appearance of this scaffold was different from the original meniscal tissue at the midterm follow-up. The treatment survival rates of 87.9% of the medial scaffolds and 86.9% of the lateral scaffolds in the present study compared favorably with those published concerning meniscal allograft transplantation after total meniscectomy.
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http://dx.doi.org/10.1177/0363546520913528DOI Listing
May 2020

Single-Stage Autologous Chondrocyte-Based Treatment for the Repair of Knee Cartilage Lesions: Two-Year Follow-up of a Prospective Single-Arm Multicenter Study.

Am J Sports Med 2020 05 8;48(6):1327-1337. Epub 2020 Apr 8.

Antwerp Orthopedic Center, AZ Monica, Antwerp, Belgium.

Background: There is an unmet need for a single-stage cartilage repair treatment that is cost-effective and chondrocyte-based.

Purpose: To evaluate the safety and preliminary efficacy of autologous freshly isolated primary chondrocytes and bone marrow mononucleated cells (MNCs) seeded into a PolyActive scaffold in patients with symptomatic cartilage lesions of the knee.

Study Design: Case series; Level of evidence, 4.

Methods: A total of 40 patients with symptomatic knee cartilage lesions were treated with freshly isolated autologous chondrocytes combined with bone marrow MNCs delivered in a biodegradable load-bearing scaffold. The treatment requires only 1 surgical intervention and is potentially a cost-effective alternative to autologous chondrocyte implantation. The primary chondrocytes and bone marrow MNCs were isolated, washed, counted, mixed, and seeded into a load-bearing scaffold in the operating room. Patients were followed up at 3, 6, 12, 18, and 24 months. Primary endpoints were treatment-related adverse events up to 3 months, adverse implant effects between 3 and 24 months, and the implant success rate at 3 months as measured by lesion filling.

Results: Successful lesion filling (≥67% on magnetic resonance imaging) was found in 40 patients at 3 months and in 32 of the 32 patients analyzed at 24 months. Significant improvement over baseline was found for visual analog scale for pain from 3 months onward; Knee injury and Osteoarthritis Outcome Score (KOOS)-Pain and KOOS-Activities of Daily Living from 6 months onward; for KOOS-Symptoms and Stiffness, KOOS-Quality of Life and International Knee Documentation Committee from 12 months onward; and for KOOS-Sport and Recreation from 18 months onward. Hyaline-like repair tissue was found in 22 of 31 patients available for biopsy. Arthralgia and joint effusion were the most common adverse events. Scaffold delamination and adhesions led to removal of the implant in 2 patients.

Conclusion: The treatment of knee cartilage lesions with autologous primary chondrocytes and bone marrow MNCs, both isolated and seeded into a load-bearing PolyActive scaffold within a single surgical intervention, is safe and clinically effective. Good lesion fill and sustained clinically important and statistically significant improvement in all patient-reported outcome scores were found throughout the 24-month study. Hyaline-like cartilage was observed on biopsy specimen in at least 22 of the 40 patients.

Registration: NCT01041885 (ClinicalTrials.gov identifier).
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http://dx.doi.org/10.1177/0363546520912444DOI Listing
May 2020

ACL reconstruction combined with lateral monoloop tenodesis can restore intact knee laxity.

Knee Surg Sports Traumatol Arthrosc 2020 Apr 25;28(4):1159-1168. Epub 2020 Jan 25.

Biomechanics Group, Department of Mechanical Engineering, Imperial College London, London, SW7 2AZ, UK.

Purpose: An anterior cruciate ligament (ACL) injury is often combined with injury to the lateral extra-articular structures, which may cause a combined anterior and rotational laxity. It was hypothesised that addition of a 'monoloop' lateral extra-articular tenodesis (mLET) to an ACL reconstruction would restore anteroposterior, internal rotation and pivot-shift laxities better than isolated ACL reconstruction in combined injuries.

Method: Twelve cadaveric knees were tested, using an optical tracking system to record the kinematics through 0°-100° of knee flexion with no load, anterior and posterior translational forces (90 N), internal and external rotational torques (5 Nm), and a combination of an anterior translational (90 N) plus internal rotational load (5 Nm). They were tested intact, after sectioning the ACL, sectioning anterolateral ligament (ALL), iliotibial band (ITB) graft harvest, releasing deep ITB fibres, hamstrings tendon ACL reconstruction, mLET combined with ACL reconstruction, and isolated mLET. Two-way repeated-measures ANOVA compared laxity data across knee states and flexion angles. When differences were found, paired t tests with Bonferroni correction were performed.

Results: In the ACL-deficient knee, cutting the ALL significantly increased anterior laxity only at 20°-30°, and only significantly increased internal rotation at 50°. Additional deep ITB release significantly increased anterior laxity at 40°-90° and caused a large increase of internal rotation at 20°-100°. Isolated ACL reconstruction restored anterior drawer, but significant differences remained in internal rotation at 30°-100°. After adding an mLET there were no remaining differences with anterior translation or internal rotation compared to the intact knee. With the combined injury, isolated mLET allowed abnormal anterior translation and rotation to persist.

Conclusions: Cutting the deep fibres of the ITB caused large increases in tibial internal rotation laxity across the range of knee flexion, while cutting the ALL alone did not. With ACL deficiency combined with anterolateral deficiency, ACL reconstruction alone was insufficient to restore native knee rotational laxity. However, combining a 'monoloop' lateral extra-articular tenodesis with ACL reconstruction did restore native knee laxity.
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http://dx.doi.org/10.1007/s00167-019-05839-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7148266PMC
April 2020

Scaffolds for Knee Chondral and Osteochondral Defects: Indications for Different Clinical Scenarios. A Consensus Statement.

Cartilage 2020 Jan 15:1947603519894729. Epub 2020 Jan 15.

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.

Objective: To develop patient-focused consensus guidelines on the indications for the use of scaffolds to address chondral and osteochondral femoral condyle lesions.

Design: The RAND/UCLA Appropriateness Method (RAM) was used to develop patient-specific recommendations by combining the best available scientific evidence with the collective judgement of a panel of experts guided by a core panel and multidisciplinary discussers. A list of specific clinical scenarios was produced regarding adult patients with symptomatic lesions without instability, malalignment, or meniscal deficiency. Each scenario underwent discussion and a 2-round vote on a 9-point Likert-type scale (range 1-3 "inappropriate," 4-6 "uncertain," 7-9 "appropriate"). Scores were pooled to generate expert recommendations.

Results: Scaffold (chondral vs. osteochondral), patient characteristics (age and sport activity level), and lesion characteristics (etiology, size, and the presence of osteoarthritis [OA]) were considered to define 144 scenarios. The use of scaffold-based procedures was considered appropriate in all cases of chondral or osteochondral lesions when joints are not affected by OA, while OA joints presented more controversial results. The analysis of the evaluated factors showed a different weight in influencing treatment appropriateness: the presence of OA influenced 58.3% of the indications, while etiology, size, and age were discriminating factors in 54.2%, 29.2%, and 16.7% of recommendations, respectively.

Conclusions: The consensus identified indications still requiring investigation, but also the convergence of the experts in several scenarios defined appropriate or inappropriate, which could support decision making in the daily clinical practice, guiding the use of scaffold-based procedures for the treatment of chondral and osteochondral knee defects.
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http://dx.doi.org/10.1177/1947603519894729DOI Listing
January 2020

Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.

Am J Sports Med 2020 02 15;48(2):285-297. Epub 2020 Jan 15.

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Background: Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.

Hypothesis: We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals.

Study Design: Randomized controlled trial; Level of evidence, 1.

Methods: This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively.

Results: A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52; < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( = .003) and KOOS ( = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( = .11).

Conclusion: The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery.

Registration: NCT02018354 ( ClinicalTrials.gov identifier).
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http://dx.doi.org/10.1177/0363546519896333DOI Listing
February 2020

A landmark-based 3D analysis reveals a narrower tibial plateau and patella in trochlear dysplastic knees.

Knee Surg Sports Traumatol Arthrosc 2020 Jul 2;28(7):2224-2232. Epub 2019 Dec 2.

Antwerp Orthopaedic Center, AZ Monica Hospitals, Antwerp, Belgium.

Purpose: The trochlear dysplastic femur has a specific morphotype previously characterised by not only dysplastic features of the trochlea but also by specific features of the notch and posterior femur. In this study the morphology of the tibia and patella was investigated to gain further insight in the complete geometrical complexity of the trochlear dysplastic knee.

Methods: Arthro-CT scan-based 3D models of 20 trochlear dysplastic and 20 normal knees were uniformly scaled and landmarks and landmark-based reference planes were created to quantify a series of morphometric characteristics of the tibia and patella.

Results: In the mediolateral direction, the 3D-analysis revealed a 3% smaller medial tibial plateau (30.4 ± 1.6 mm vs 31.5 ± 1.6 mm), a 3% smaller overall width of the tibial plateau (73.6 ± 2.0 mm vs 75.7 ± 2.0 mm), a 16% smaller medial facet (17.3 ± 2.2 mm vs 20.1 ± 1.3 mm) and a 4% smaller overall width of the patella (41.7 ± 2.5 mm vs 43.4 ± 2.3 mm) in trochlear dysplastic knees. In the anteroposterior direction, the lateral tibial plateau of trochlear dysplastic knees was 5% larger (37.2 ± 2.3 mm vs 35.5 ± 3.1 mm). A correlation test between the width of the femur and the width of the tibia revealed that trochlear dysplastic knees show less correspondence between the femur and tibia compared to normal knees.

Conclusion: Significant differences in the morphology of the tibial plateau and patella were detected between trochlear dysplastic and normal knees. Both in the trochlear dysplastic tibial plateau and patella a narrower medial compartment leads to a significant smaller overall mediolateral width. These findings are important for the understanding of knee biomechanics and the design of total knee arthroplasty components.

Level Of Evidence: III.
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http://dx.doi.org/10.1007/s00167-019-05802-xDOI Listing
July 2020

Meniscus Scaffolds for Partial Meniscus Defects.

Clin Sports Med 2020 Jan;39(1):83-92

Orthoca, Kielsevest 14, Antwerp 2018, Belgium. Electronic address:

The meniscus is a crucial player in knee joint homeostasis. Loss of meniscus tissue can result in early onset of clinical symptoms like pain and loss of function, and structural degeneration of the articular cartilage. In case of a symptomatic segmental defect of the medial or lateral meniscus, different innovative options using biological or synthetic scaffolds are now available to regenerate meniscuslike tissue, with the aim of allowing a satisfactory clinical improvement to patients. However, the role of any of these procedures in terms of chondroprotection is questionable, and the overall outcomes in the long term still can be improved.
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http://dx.doi.org/10.1016/j.csm.2019.08.011DOI Listing
January 2020

Allografts in joint reconstruction: ESSKA making a difference.

Knee Surg Sports Traumatol Arthrosc 2019 06 10;27(6):1701-1703. Epub 2019 May 10.

Department of Knee Surgery, Lyon Ortho Clinic, Lyon, France.

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http://dx.doi.org/10.1007/s00167-019-05514-2DOI Listing
June 2019

Treatment options for the symptomatic post-meniscectomy knee.

Knee Surg Sports Traumatol Arthrosc 2019 Jun 11;27(6):1817-1824. Epub 2019 Mar 11.

Antwerp Orthopaedic Center, AZ Monica Hospitals, Antwerp, Belgium.

Purpose: To provide a current review on the evidence for management of the symptomatic meniscus-deficient knee.

Methods: A literature review was performed detailing the natural history and origin of symptoms in a meniscus-deficient knee, in addition to strategies for non-surgical management, meniscus scaffolds, meniscus allograft transplantation (MAT), isolated cartilage repair, unloading osteotomies, meniscus prosthesis, and joint replacements which were revealed as treatment possibilities.

Results: Meniscus deficiency was recognized to lead to an early onset knee osteoarthritis (OA). A subset of patients develop post-meniscectomy syndrome: dull and nagging pain after a short pain-free interval subsequently to meniscectomy, which can be accompanied by transient effusions. Evidence for non-surgical management of post-meniscectomy knee pain is lacking. Two available meniscus scaffolds, indicated for symptomatic segmental meniscus deficiency, show pain relief at mid-term follow-up, and effect on joint preservation is unclear. MAT represents a durable solution for sub/total meniscus deficiency (80% survival at 10 years), but it is still considered a temporary solution for post-meniscectomy pain. MAT may also reduce the progression of OA. Isolated cartilage repair without a meniscus reconstruction is commonly performed, but better results were reported with preserved or reconstructed menisci. Osteotomies are used in the combination of misaligned knee and meniscus reconstruction or as pain solution for irreversible unilateral knee structural changes following a meniscectomy. Polycarbonate-urethane medial meniscus prosthesis is currently undergoing clinical trial. Joint replacements should be limited to later stages of post-meniscectomy OA.

Conclusions: Post-meniscectomy pain syndrome and post-meniscectomy knee OA are common findings after meniscus resection. Short-term pain relief is provided by non-surgical management, mid-term pain relief by meniscus scaffolds, and long-term relief by MAT, though each has differing indications. In later stages, osteotomies and joint replacements are indicated.

Level Of Evidence: IV.
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http://dx.doi.org/10.1007/s00167-019-05424-3DOI Listing
June 2019

The use of allograft tendons in primary ACL reconstruction.

Knee Surg Sports Traumatol Arthrosc 2019 Jun 4;27(6):1754-1770. Epub 2019 Mar 4.

University Hospital Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, UK.

Purpose: Graft choice in primary anterior cruciate ligament (ACL) reconstruction remains controversial. The use of allograft has risen exponentially in recent years with the attraction of absent donor site morbidity, reduced surgical time and reliable graft size. However, the published evidence examining their clinical effectiveness over autograft tendons has been unclear. The aim of this paper is to provide a current review of the clinical evidence available to help guide surgeons through the decision-making process for the use of allografts in primary ACL reconstruction.

Methods: The literature in relation to allograft healing, storage, sterilisation, differences in surgical technique and rehabilitation have been reviewed in addition to recent comparative studies and all clinical systematic reviews and meta-analyses.

Results: Early reviews have indicated a higher risk of failure with allografts due to association with irradiation for sterilisation and where rehabilitation programs and post-operative loading may ignore the slower incorporation of allografts. More recent analysis indicates a similar low failure rate for allograft and autograft methods of reconstruction when using non-irradiated allografts that have not undergone chemically processing and where rehabilitation has been slower. However, inferior outcomes with allografts have been reported in young (< 25 years) highly active patients, and also when irradiated or chemically processed grafts are used.

Conclusion: When considering use of allografts in primary ACL reconstruction, use of irradiation, chemical processing and rehabilitation programs suited to autograft are important negative factors. Allografts, when used for primary ACL reconstruction, should be fresh frozen and non-irradiated. Quantification of the risk of use of allograft in the young requires further evaluation.

Levels Of Evidence: III.
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http://dx.doi.org/10.1007/s00167-019-05440-3DOI Listing
June 2019

The use of allograft tissue in posterior cruciate, collateral and multi-ligament knee reconstruction.

Knee Surg Sports Traumatol Arthrosc 2019 Jun 1;27(6):1791-1809. Epub 2019 Mar 1.

University Hospital Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, UK.

Purpose: Currently both autograft and allograft tissues are available for reconstruction of posterior cruciate, collateral and multi-ligament knee injuries. Decision-making is based on a complex interplay between anatomical structures, functional bundles and varying biomechanical requirements. Despite theoretically better biological healing and reduced risk of disease transmission autografts are associated with donor site morbidity as well as being limited by size and quantity. The use of allografts eliminates donor-site morbidity but raises cost and issues of clinical effectiveness. The purpose of this paper is to review current concepts and evidence for the use of allografts in primary posterior cruciate, collateral and multi-ligament reconstructions.

Methods: A narrative review of the relevant literature was conducted for PCL, collateral ligament and multi-ligament knee reconstruction. Studies were identified using a targeted and systematic search with focus on recent comparative studies and all clinical systematic reviews and meta-analyses. The rationale and principles of management underpinning the role of allograft tissue were identified and the clinical and functional outcomes were analysed. Finally, the position of postoperative physiotherapy and rehabilitation was identified.

Results: The review demonstrated paucity in high quality and up-to-date results addressing the issue especially on collaterals and multi-ligament reconstructions. There was no significant evidence of superiority of a graft type over another for PCL reconstruction. Contemporary principles in the management of posterolateral corner, MCL and multi-ligament injuries support the use of allograft tissue.

Conclusion: The present review demonstrates equivalent clinical results with the use of autografts or allografts. It remains, however, difficult to generate a conclusive evidence-based approach due to the paucity of high-level research. When confronted by the need for combined reconstructions with multiple grafts, preservation of synergistic muscles, and adapted postoperative rehabilitation; the current evidence does offer support for the use of allograft tissue.

Level Of Evidence: IV.
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http://dx.doi.org/10.1007/s00167-019-05426-1DOI Listing
June 2019

Treatment of unstable knee osteochondritis dissecans in the young adult: results and limitations of surgical strategies-The advantages of allografts to address an osteochondral challenge.

Knee Surg Sports Traumatol Arthrosc 2019 Jun 6;27(6):1726-1738. Epub 2018 Dec 6.

Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA.

Joint surface incongruence resulting from osteochondritis dissecans (OCD) alters the articular physiologic congruence, increasing the contact stress on adjacent joint surfaces and accelerating wear and the cascade of joint degeneration. Accordingly, the restoration of articular surface integrity is of major importance, especially in young adults where, in lesions left untreated or following simple fragment excision, early osteoarthritis can be anticipated. Therefore, the treatment algorithm in unstable knee OCD of the young adult foresees surgical options to restore the articular surface. Several procedures have been proposed, including refixation of the detached fragment bone marrow stimulation, osteochondral autograft implantation, fresh osteochondral allograft transplantation, and cell-based or cell-free regenerative techniques. The aim of this review was to summarize the evidence for these surgical strategies, reporting their results and limitations. The overall evidence documents positive results for each of the assorted surgical procedures applied to treat unstable OCD, thus indicating support for their selected use to treat osteochondral defects paying particular attention to their specific indications for the lesion characteristics. The fixation of a good quality fragment should be pursued as a first option, while unfixable small lesions may benefit from autografts. For large lesions, available cell-based or cell-free osteochondral scaffold are a feasible solution but with limitation in terms of regenerated tissue quality. In this light, fresh allografts may offer articular surface restoration with viable physiologic osteochondral tissue providing a predictably successful outcome, and therefore they may currently represent the most suitable option to treat unstable irreparable OCD lesion in young adults. LEVEL OF EVIDENCE: V.
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http://dx.doi.org/10.1007/s00167-018-5316-5DOI Listing
June 2019

Learning curve with a new primary total knee arthroplasty implant: a multicenter perspective with more than 2000 patients.

Arthroplast Today 2018 Sep 9;4(3):348-353. Epub 2018 Jul 9.

Monica Camputs O.L.V., Middelares Hospital, Antwerpen, Belgium.

Background: This study provides an example for evaluating learning curve when introducing a new knee system.

Methods: Thirty-five investigators across 22 sites prospectively implanted 843 subjects with currently available products (group A). Seventy-seven investigators across 48 sites prospectively implanted 2330 subjects with the ATTUNE Knee System; in which the first 10 subjects for each surgeon were the learning curve cases (group B, N = 611), and the later subjects were designated as group C (N = 1719). Surgical time, rates of intraoperative and early postoperative complications, and patient-reported outcome measures (PROMs) at a minimum of 1 year were compared.

Results: Mean (standard deviation) surgical time was 72.0 (21.6) minutes for group A, 83.0 (24.2) for group B, and 72.1 (24.1) for group C ( < .001 for group B vs group C;  = .955 for group C vs group A). Intraoperative, early (<90 day) complication rates, and PROMs were similar for all groups.

Conclusions: The new knee system learning curve was characterized by a slightly longer surgical time with no negative impact on complications or PROMs.

Level Of Evidence: III.
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http://dx.doi.org/10.1016/j.artd.2018.05.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6123238PMC
September 2018

Correction to: Peak stresses shift from femoral tunnel aperture to tibial tunnel aperture in lateral tibial tunnel ACL reconstructions: a 3D graft-bending angle measurement and finite-element analysis.

Knee Surg Sports Traumatol Arthrosc 2018 02;26(2):518

Department of Orthopaedics and Traumatology, University Hospital Ghent, De pintelaan 185, 9000, Ghent, Belgium.

Unfortunately, one of the co-author's name was missed in the original online publication of this article. The name should be included as sixth author in the author group.
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http://dx.doi.org/10.1007/s00167-017-4821-2DOI Listing
February 2018

Peak stresses shift from femoral tunnel aperture to tibial tunnel aperture in lateral tibial tunnel ACL reconstructions: a 3D graft-bending angle measurement and finite-element analysis.

Knee Surg Sports Traumatol Arthrosc 2018 02 9;26(2):508-517. Epub 2017 Nov 9.

Department of Orthopaedics and Traumatology, University Hospital Ghent, De pintelaan 185, 9000, Ghent, Belgium.

Purpose: To investigate the effect of tibial tunnel orientation on graft-bending angle and stress distribution in the ACL graft.

Methods: Eight cadaveric knees were scanned in extension, 45°, 90°, and full flexion. 3D reconstructions with anatomically placed anterior cruciate ligament (ACL) grafts were constructed with Mimics 14.12. 3D graft-bending angles were measured for classic medial tibial tunnels (MTT) and lateral tibial tunnels (LTT) with different drill-guide angles (DGA) (45°, 55°, 65°, and 75°). A pivot shift was performed on 1 knee in a finite-element analysis. The peak stresses in the graft were calculated for eight different tibial tunnel orientations.

Results: In a classic anatomical ACL repair, the largest graft-bending angle and peak stresses are seen at the femoral tunnel aperture. The use of a different DGA at the tibial side does not change the graft-bending angle at the femoral side or magnitude of peak stresses significantly. When using LTT, the largest graft-bending angles and peak stresses are seen at the tibial tunnel aperture.

Conclusion: In a classic anatomical ACL repair, peak stresses in the ACL graft are found at the femoral tunnel aperture. When an LTT is used, peak stresses are similar compared to classic ACL repairs, but the location of the peak stress will shift from the femoral tunnel aperture towards the tibial tunnel aperture.

Clinical Relevance: the risk of graft rupture is similar for both MTTs and LTTs, but the location of graft rupture changes from the femoral tunnel aperture towards the tibial tunnel aperture, respectively.

Level Of Evidence: I.
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http://dx.doi.org/10.1007/s00167-017-4739-8DOI Listing
February 2018

Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial.

Am J Sports Med 2018 01 10;46(1):171-180. Epub 2017 Oct 10.

NanoBiotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.

Background: Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement.

Purpose: To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study.

Study Design: Randomized controlled trial; Level of evidence, 2.

Methods: Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form-36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively).

Results: The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group ( P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain subscale ( P = .0085) and Role Emotional Health subscale ( P = .0410), as well as CGI-C values ( P = .01) compared with saline control. Significant differences between groups were detected in change from baseline to 12 months in bone marrow lesion size as assessed on MRI and osteophytes in the central zone of the lateral femoral condyle, both in favor of the APS group ( P = .041 and P = .032, respectively). There were no significant differences between APS and control groups in other measured secondary endpoints.

Conclusion: This study provides evidence to support the safety and clinical improvement at 1-year follow-up of a single intra-articular injection of APS in patients affected by knee OA. Treatment with APS or a saline injection provided significant pain relief over the course of the study with differences becoming apparent at between 6 and 12 months after treatment.

Trial Registration: NCT02138890 ( ClinicalTrials.gov identifier).
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http://dx.doi.org/10.1177/0363546517732734DOI Listing
January 2018

A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years.

Knee Surg Sports Traumatol Arthrosc 2018 Sep 14;26(9):2704-2715. Epub 2017 Sep 14.

Humanitas University Department of Biomedical Sciences - Humanitas Clinical and Research Center, Milan, Italy.

Purpose: The increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions.

Methods: In this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness.

Results: A statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups.

Conclusions: This study highlighted the safety and potential of a biomimetic implant. While no statistically significant differences were found compared to BMS for chondral lesions, this procedure can be considered a suitable option for the treatment of osteochondral lesions.

Level Of Evidence: I.
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http://dx.doi.org/10.1007/s00167-017-4707-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105149PMC
September 2018