Incidence of Complications After Tibial Tubercle Osteotomy and Tibial Tubercle Osteotomy With Distalization.

BACKGROUND: Tibial tubercle osteotomy (TTO) is a well-established surgical treatment option for patellofemoral instability and pain. TTO with distalization (TTO-D) is indicated for patients with patellofemoral instability, patellar malalignment, and patella alta. The current literature demonstrates several complications that may be associated with TTO, with reportedly higher rates of complications associated with TTO-D. PURPOSE: To analyze and compare complication rates after TTO without distalization (TTO-ND) and TTO-D and assess risk factors associated with complications. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: All skeletally mature patients who underwent TTO with or without distalization by a single surgeon between September 2014 and May 2023 with a minimum of 6 months of clinical follow-up were retrospectively reviewed. Patient factors, surgical indications, perioperative data, and complications were collected via a retrospective review of electronic medical records. Concomitant procedures were categorized as intra-articular, extra-articular, and osteotomies. RESULTS: A total of 251 TTOs (117 TTO-D, 134 TTO-ND) were included in the study group. Postoperative complications were observed in 15 operations (6%), with arthrofibrosis as the most common complication (10 operations [4%]). TTO-D and TTO-ND had similar rates of complication (5% vs 7%; P = .793). Clinical nonunion was observed in 3 operations (3%) in the TTO-D cohort and 1 operation (1%) in the TTO-ND cohort. In the TTO-D cohort, concomitant intra-articular procedures were significantly associated with an increased likelihood of complications in a univariate model. In the TTO-ND cohort, an increased tourniquet time was significantly associated with an increased likelihood of complications in a univariate model. For all TTOs as well as the TTO-D and TTO-ND cohorts, there were no significant associations between patient or surgical variables in a multivariate model. CONCLUSION: TTO with and without distalization is a safe procedure with low rates of complication. TTO-D was not associated with a higher rate of complications compared with TTO-ND. There was no association between complications and surgical variables for TTO procedures.

Decreased Effective Patellar Tendon Length following Distalization Tibial Tubercle Osteotomy without Patellar Tendon Tenodesis.

Background: Distalization tibial tubercle osteotomy (TTO) is an effective treatment for improving patellar height in patients with patella alta associated with patellofemoral instability and cartilage lesions. The addition of a patellar tendon tenodesis has been suggested; nonetheless, concerns exist regarding possible increased patellofemoral cartilage stresses. Purpose: To evaluate pre- and postoperative patellar tendon length and alignment parameters on magnetic resonance imaging (MRI), as well as patient-reported outcome measures (PROMs) after distalization TTO without patellar tendon tenodesis. Study Design: Case series; Level of evidence, 4. Methods: Twenty skeletally mature patients who underwent distalization TTO with or without anteromedialization at our institution between December 2014 and August 2021 were included. All patients underwent pre- and postoperative MRIs of the affected knee. The Caton-Deschamps index (CDI), the axial and sagittal tibial tubercle-trochlear groove (TT-TG) distances, the distances from the tibial plateau to the patellar tendon insertion and the tibial tubercle, and the patellar tendon length were assessed. PROMs included the International Knee Documentation Committee Subjective Knee Evaluation Form, the Knee injury and Osteoarthritis Outcome Score-Quality of Life subscale, the Kujala Anterior Knee Pain Scale, and the Veterans RAND 12-Item Health Survey mental and physical component scores. Results: The mean patient age at surgery was 27.4 years (range, 14-42 years). Radiographic parameters demonstrated improved patellar height (CDI decreased from 1.36 to 1.11; P < .001) after distalization TTO. The distance from the tibial plateau to the patellar tendon insertion significantly decreased from 20.1 mm preoperatively to 17.9 mm postoperatively (P < .020), and the patellar tendon length decreased from 53.4 mm preoperatively to 46.0 mm postoperatively (P < .001). The patellar tendon insertion was not distalized after distalization TTO, likely because of scarring of the patellar tendon proximal to the osteotomy site. Patients demonstrated significant pre- to postoperative improvements on all PROMs (P≤ .024 for all ). There were 4 (20%) complications-2 cases of arthrofibrosis, 1 postoperative infection, and 1 osteotomy delayed union. Conclusion: Distalization TTO without patellar tendon tenodesis was associated with improved radiographic outcomes and PROMs. It provides an additional tool for surgical management of patellofemoral pathology with associated patella alta.

Medial Meniscus Posterior Root Tears Lead to Changes in Joint Contact Mechanics at Low Flexion Angles During Simulated Gait.

BACKGROUND: Previous biomechanical studies evaluating medial meniscus posterior root tears (MMPRTs) are limited to low loads applied at specified loading angles, which cannot capture the effects of MMPRTs during the multidirectional forces and moments placed across the knee during physiological activities. PURPOSE: To quantify the effects of MMPRTs on knee joint contact mechanics during simulated gait. STUDY DESIGN: Controlled laboratory study. METHODS: Six human cadaveric knees were mounted on a robotic simulator programmed to apply dynamic forces, moments, and flexion angles to mimic level walking. Twelve cycles of multidirectional and dynamic standard gait input waveforms, normalized to specimen-specific body weight, were applied to the following conditions: (1) native, intact meniscus and (2) MMPRT. Peak contact stress, contact area, and the position of the weighted center of contact across the medial tibial plateau throughout the stance phase of gait were quantified using an electronic sensor placed across the medial tibial plateau. The difference between the intact state and MMPRT condition was calculated for each metric, and then the means and 95% CIs were computed. RESULTS: Despite heterogeneity in knee contact forces, MMPRTs significantly increased peak contact stress by a mean of 2 MPa across 20% to 37% of the simulated gait cycle and significantly decreased the contact area by a mean of 200 mm2 across 16% to 60% of the simulated gait cycle in comparison with the native state. There was no significant difference in the position of the weighted center of contact, in either the anterior-posterior or medial-lateral directions, after MMPRT. CONCLUSION: MMPRTs led to both a significant increase in peak contact stress and decreased contact areas for a portion of the simulated gait cycle ranging from 20% to 37% of gait, during which time the femur was flexed <15°. CLINICAL RELEVANCE: Contact mechanics are significantly affected after MMPRTs during early to midstance and at knee flexion angles lower than demonstrated previously. These data provide further biomechanical justification for treating MMPRTs.

Impact of Wiberg Patellar Type on Outcomes and Survival Following Cell-Based Cartilage Repair for Patellar Chondral Lesions at Midterm Follow-up.

BACKGROUND: Cell-based cartilage repair procedures of the patellofemoral joint have less reliable outcomes than those of the tibiofemoral joint. No previous studies have evaluated the influence of patellar shape on cell-based cartilage repair outcomes. Patellar dysplasia may predispose patients to worse outcomes after cell-based cartilage repair. PURPOSE/HYPOTHESIS: The purpose of this study was to evaluate the relationship between Wiberg patellar type and outcomes after cell-based cartilage repair (autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation) for the treatment of patellar chondral lesions at a minimum 2-year follow-up. It was hypothesized that Wiberg classification of patellar shape would have no effect on patient-reported outcome measures (PROMs) or graft survival. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Patients undergoing autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation for full-thickness patellar chondral defects between 2016 and 2020 were retrospectively reviewed after institutional review board approval. The change in PROMs, including International Knee Documentation Committee (IKDC), Kujala, and Veterans RAND 12-item Health Survey Mental and Physical scores, from pre- to postoperatively and the percentage of patients who achieved the minimal clinically important difference (MCID) for IKDC and Kujala scores were compared for the Wiberg type A versus Wiberg type B versus Wiberg type C groups. The log-rank test was used to evaluate for differences in survival between subgroups. RESULTS: A total of 59 patients (63 knees) were included, with a mean age of 33.3 ± 8.6 years, median body mass index of 26.0 (IQR, 21.8-30.2), and median follow-up time of 3.5 years (IQR, 2.6-4.2 years). In total, 26 (41%) patellae were Wiberg type A, 29 (46%) were Wiberg type B, and 8 (13%) were Wiberg type C. There were no differences between Wiberg type A versus Wiberg type B versus Wiberg type C groups with respect to change in PROMs from pre- to postoperatively or the percentage of patients who achieved the MCID for IKDC or Kujala scores (P > .05 for all). There were no differences in survival between groups (P = .45). CONCLUSION: Wiberg patellar type has no effect on patient-reported outcomes or graft survival at midterm follow-up. Patellar dysplasia should not be seen as a contraindication for cell-based cartilage repair procedures.

Short-Term Outcomes of Concomitant Patellofemoral Arthroplasty and Medial Patellofemoral Ligament Reconstruction to Treat Concurrent Patellofemoral Arthritis and Patellar Instability.

The purpose of this study was to evaluate the efficacy of combined patellofemoral arthroplasty (PFA) and medial patellofemoral ligament (MPFL) reconstruction in patients with patellofemoral arthritis in the setting of concomitant patellar instability. Patients who underwent single-stage, combined PFA and MPFL reconstruction by a single surgeon at a tertiary-care orthopaedic center between 2016 and 2021 were identified. Postoperative radiographic and clinical outcomes at a minimum of 6 months were recorded using patient-reported outcome measures, including International Knee Documentation Committee (IKDC), Kujala, and VR-12. Early complications and rates of recurrent instability were also recorded. Of the 16 patients who met inclusion and exclusion criteria, 13 patients were available for final follow-up (81%; 51.7 ± 7.2 years, 11 females, 2 males) with a mean clinical follow-up of 1.3 ± 0.5 years (range: 0.5-2.3 years). Patients experienced significant improvements in patellar tilt and multiple patient-reported outcome metrics postoperatively, including IKDC, Kujala, VR-12 Mental Health, and VR-12 Physical Health. At the time of the most recent follow-up, no patient had experienced a postoperative dislocation or subluxation event. The findings suggest that concurrent PFA and MPFL reconstruction are associated with significant improvements in multiple patient-reported outcomes. Further studies are needed to evaluate the duration of clinical benefits achieved with this combined intervention.

Measure Twice, Cut Once: The Future of Digitally Planned Knee Osteotomies.

It is important to highlight the use of patient-specific cutting guides for knee joint osteotomies. Rationale, pitfalls, and planning of conventional osteotomy techniques are examined. The benefits of using patient-specific guides focusing on the potential for improved accuracy, efficiency, and safety are reviewed. The versatility of guides to manipulate the slope in both the coronal and sagittal planes, as well as its ability to accommodate concomitant procedures, is discussed. The time and cost differentials between standard cutting guides and three-dimensional-guided templating are also discussed.

A modified Delphi consensus statement on patellar instability: part I.

Aims: The aim of this study was to establish consensus statements on the diagnosis, nonoperative management, and indications, if any, for medial patellofemoral complex (MPFC) repair in patients with patellar instability, using the modified Delphi approach. Methods: A total of 60 surgeons from 11 countries were invited to develop consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest within patellar instability. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered to be unanimous. Results: Of 27 questions and statements on patellar instability, three achieved unanimous consensus, 14 achieved strong consensus, five achieved consensus, and five did not achieve consensus. Conclusion: The statements that reached unanimous consensus were that an assessment of physeal status is critical for paediatric patients with patellar instability. There was also unanimous consensus on early mobilization and resistance training following nonoperative management once there is no apprehension. The statements that did not achieve consensus were on the importance of immobilization of the knee, the use of orthobiologics in nonoperative management, the indications for MPFC repair, and whether a vastus medialis oblique advancement should be performed.

A modified Delphi consensus statement on patellar instability: part II.

Aims: The aim of this study was to establish consensus statements on medial patellofemoral ligament (MPFL) reconstruction, anteromedialization tibial tubercle osteotomy, trochleoplasty, and rehabilitation and return to sporting activity in patients with patellar instability, using the modified Delphi process. Methods: This was the second part of a study dealing with these aspects of management in these patients. As in part I, a total of 60 surgeons from 11 countries contributed to the development of consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered unanimous. Results: Of 41 questions and statements on patellar instability, none achieved unanimous consensus, 19 achieved strong consensus, 15 achieved consensus, and seven did not achieve consensus. Conclusion: Most statements reached some degree of consensus, without any achieving unanimous consensus. There was no consensus on the use of anchors in MPFL reconstruction, and the order of fixation of the graft (patella first versus femur first). There was also no consensus on the indications for trochleoplasty or its effect on the viability of the cartilage after elevation of the osteochondral flap. There was also no consensus on postoperative immobilization or weightbearing, or whether paediatric patients should avoid an early return to sport.

Multi-Surface Cartilage Defects about the Knee Treated with Cartilage Restoration Procedures Show Good Outcomes and Survivorship at Minimum 2-Year Follow-Up.

OBJECTIVE: We aimed to evaluate the outcomes, survivorship, and complications following multi-surface cartilage procedures at minimum 2-year follow-up. DESIGN: Patients with either (1) single-surface osteochondral allograft transplantation (OCAT) with third-generation matrix-induced autologous cultured chondrocyte implantation (MACI) or particulated juvenile cartilage implantation (DeNovo), or (2) multiple-surface OCAT ± associated MACI/DeNovo procedures for grade IV chondral or osteochondral defects about the knee with minimum 2-year follow-up were analyzed. Patient-reported outcome measures (PROMs), including International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales, were obtained preoperatively and at minimum 2 years postoperatively. The percentage of patients who met the minimal clinically important difference (MCID) for each PROM was reported. Failure was defined as revision OCAT, conversion to patellofemoral/total/unicompartmental joint arthroplasty, or Arthrosurface HemiCAP placement. RESULTS: Of 257 patients identified, 35 were included. There was a significant increase in IKDC, KOOS-pain, KOOS-symptom, KOOS-sport, and KOOS-quality of life scores from preoperative to postoperative evaluation (P < 0.03 for all). More than 50% of patients met the MCID for each PROM. There were 2 failures, 1 of the patella and 1 of the medial femoral condyle, at 39.7 and 38.6 months postoperatively, respectively. DISCUSSION: Multi-surface cartilage procedures are a safe, efficacious treatment option for multifocal cartilage defects about the knee at short-term follow-up.

Predilection of Patellofemoral Cartilage Lesions in Patients with Posterior Medial Meniscal Root Lesions.

OBJECTIVE: The present study aims to compare the presence and severity of patellofemoral osteoarthritis between patients with root lesions and non-root lesions. DESIGN: A total of 102 patients were included in this study (51 root lesions and 51 non-root lesions). The root lesion cohort was matched to a non-root lesion cohort based on sex, body mass index, and age at the time of surgery. Radiographic evaluation with modified Outerbridge scoring of MRI of the knee was performed to determine the severity of degeneration of the knee joint preoperatively. Mann-Whitney and Independent t tests were used to compare the groups. RESULTS: The root lesion group had statistically greater Outerbridge patella scores (M = 2.45 ± 1.12) and trochlear scores (M = 2.27 ± 1.37) than the non-root lesion patients (M = 1.78 ± 1.30, P = 0.006, and M = 1.55 ± 1.40, P = 0.010, respectively). When using a new scale for grading patellofemoral arthritis, the root lesion group had statistically greater scores (M = 8.33 ± 3.38) than the non-root lesion patients (M = 5.67 ± 3.07) (P < 0.001). CONCLUSION: Patients with root lesions have a greater degree of patellofemoral cartilage lesions than patients without root lesions. The presence of cartilage lesions preoperatively in root lesion patients has presented the question of whether repair is worthwhile or if one should delay surgery until arthroplasty is indicated. Future research should be carried out on outcomes of root repair surgery in patients with patellofemoral cartilage lesions, in addition to considering the patient's age, activity level, and other risk factors.

Proximal bone block with distal screw trajectory improves mechanical stability during distalization tibial tubercle osteotomy.

PURPOSE: The purpose of this study was to quantify differences in mechanical stability of a wedge-shaped distalization tibial tubercle osteotomy (TTO) with a standard technique, versus a modified technique with use of a proximal bone block and distally angled screw trajectory. METHODS: Ten fresh-frozen cadaver lower extremity specimens (five matched pairs) were utilized. Within each specimen pair, one specimen was randomly assigned to undergo a standard distalization osteotomy fixed with two bicortical 4.5-mm screws oriented perpendicular to the long axis of the tibia, and the other to undergo a distalization osteotomy with modified fixation utilizing a proximal bone block and distally angled screw trajectory. Each specimen's patella and tibia were mounted on a servo-hydraulic load frame using custom fixtures (MTS Instron). The patellar tendon was dynamically loaded to 400 N at a rate of 200 N/second for 500 cycles. Following the cyclic loading, loading to failure was done at 25 mm/min. RESULTS: The modified distalization TTO technique demonstrated significantly higher average load to failure compared to the standard distalization TTO technique (1339 N vs. 844.1 N, p < 0.001). Average maximum tibial tubercle displacement during cyclic loading was significantly smaller in the modified TTO technique group compared to the standard TTO technique (1.1 mm vs. 4.7 mm, p < 0.001). CONCLUSION: This study demonstrates that distalization TTO utilizing a modified technique with a proximal bone block and distally aimed screws is biomechanically superior to standard distalization TTO without proximal bone block and screw trajectory perpendicular to the long axis of the tibia. This increased stability may aid in reducing the reported higher complication rates (including loss of fixation, delayed union and nonunion) following distalization TTO, although future clinical outcome studies are warranted.

Improved 2-Year Freedom from Arthroplasty in Patients with High-Risk SIFK Scores and Medial Knee Osteoarthritis Treated with an Implantable Shock Absorber versus Non-Operative Care.

OBJECTIVE: Subchondral insufficiency fracture of the knee (SIFK) is associated with high rates of osteoarthritis (OA) and arthroplasty. The implantable shock absorber (ISA) is an extra-capsular implant that unloads the medial knee compartment. This study compared the 2-year freedom from arthroplasty rates in subjects with medial knee OA and SIFK when treated with an ISA versus a matched cohort of patients treated non-surgically. DESIGN: This retrospective case-control study compared 2-year conversion rates to arthroplasty in SIFK score-, age-, and body mass index (BMI)-matched control subjects without prior surgical history with ISA-implanted subjects from an ongoing prospective study. Baseline and final radiographs, and MRIs were reviewed for evaluation of meniscus or ligament injuries, insufficiency fractures, and subchondral edema. Kaplan-Meier analysis assessed survival. RESULTS: Forty-two patients (21 Control: 21 ISA), mean age = 52.3 ± 8.7 years, BMI = 29.5 ± 3.9 kg/m2, 40% female were evaluated. Both ISA and Control arms had the same numbers of low (n = 4), medium (n = 11), and high-risk (n = 6) SIFK scores. One- and 2-year freedom-from-arthroplasty rates were both 100% for ISA subjects, and 76% and 55%, respectively, for Controls (P = 0.001 for cross-group comparison). Control knees with low, medium, and high-risk SIFK scores had respective 1- and 2-year survival rates of 100% and 100%, 90% and 68% (P = 0.07 vs. ISA), and 33% and 0% (P = 0.002 vs. ISA). CONCLUSIONS: ISA intervention was strongly associated with avoidance of arthroplasty at a minimum 2 years, especially in patients with high-risk SIFK scores. SIFK severity scoring predicted relative risk of conversion to arthroplasty through at least 2 years in non-surgically treated subjects.

Patellofemoral arthroplasty conversion to total knee arthroplasty: An updated retrieval analysis and clinical outcomes.

BACKGROUND: A prior retrieval analysis found high rates of infection after conversion of PFA to TKA, but was limited by a small sample size. The purpose of this study is to perform a retrieval analysis with clinical correlation on an expanded group of patients to better understand conversion of PFA to TKA. METHOD: A retrospective review of an implant retrieval registry identified 62 conversions of PFA to TKA between 2004-2021. Implants were analyzed for wear pattern and cement fixation. Patient charts were reviewed for demographic information, perioperative data, prior and subsequent surgical procedures, complications and outcomes. Radiographs performed prior to index PFA and conversion procedures were assessed for KL grading. RESULTS: Cement fixation was present on 86% of retrieved components and wear was more pronounced on the lateral side. The most common indication for conversion to TKA was progression of OA in 46.8% of patients, followed by unexplained pain in the absence of radiographic or clinical changes (37.1%), loosening (8.1%), mechanical symptoms (4.8%), traumatic (3.2%). Thirteen patient experienced complications requiring additional procedures including arthrofibrosis (n = 4, 7.3%), PJI (n = 3, 5.5%), instability (n = 3, 5.5%), hematoma (n = 2, 3.6%) and loosening (n = 1, 1.8%). Revision components were used in 1.8% of cases and average post-conversion arc of motion was 119 degrees. CONCLUSIONS: The most common reason for PFA conversion to TKA was progression of osteoarthritis. PFA conversion to TKA is technically similar to primary TKA, but complication rates are more consistent with revision TKA in this study.

Establishing minimal detectable change thresholds for the international knee documentation committee and Kujala scores at one and two years after patellofemoral joint arthroplasty.

PURPOSE: To define the minimal detectable change (MDC) for the international knee documentation committee (IKDC) and Kujala scores one and two years after patellofemoral joint arthroplasty (PFA). METHODS: A distribution-based method (one-half the standard deviation of the mean difference between postoperative and preoperative outcome scores) was applied to establish MDC thresholds among 225 patients undergoing primary PFA at a single high-volume musculoskeletal-care center. Stability of change in MDC achievement was explored by quantifying the proportion of achievement at one- and two-year postoperative timepoints. Multivariable logistic regression analysis was performed to explore the association between sociodemographic and operative features on MDC achievement. RESULTS: MDC thresholds for the Kujala score were 10.3 (71.1% achievement) and 10.6 (70.4% achievement) at one- and two years, respectively. The MDC thresholds for the IKDC score were 11.2 (78.1% achievement) and 12.3 (69.0% achievement) at one- and two years, respectively. Predictors of achieving the MDC for the Kujala and IKDC scores at both time points were lower preoperative Kujala and IKDC scores, respectively. Preoperative thresholds of ≤ 24.1 and 7.6 for the Kujala and IKDC scores, respectively, were associated with a 90% MDC achievement probability. When preoperative thresholds approached 64.3 and 48.3 for the Kujala and IKDC, respectively, MDC achievement probability reduced to 50%. CONCLUSION: The MDC thresholds for the Kujala and IKDC scores two years after PFA were 10.6 and 12.3, respectively. Clinically significant health status changes were maintained overall, with a slight decrease in achievement rates between one and two years. MDC achievement was associated with disability at presentation, and several probability-based preoperative thresholds were defined. These findings may assist knee surgeons with patient selection and the decision to proceed with PFA by better understanding the patient-specific propensity for MDC achievement. LEVEL OF EVIDENCE: IV, retrospective case series.

An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis.

PURPOSE: To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system. METHODS: Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects' follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation. RESULTS: All 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m2, 38% female; study knee Kellgren-Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan-Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001). CONCLUSIONS: In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches. LEVEL OF EVIDENCE: II.

Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial.

BACKGROUND: Lesions of the articular cartilage, with or without involvement of the subchondral bone, are a common cause of pain and dysfunction in the knee. Although several treatment options have been developed, the majority of previous clinical trials examined patients with isolated or focal midsized defects, which rarely represent the condition found in the general population. Rather, cartilage lesions are often associated with the presence of mild to moderate osteoarthritic changes. PURPOSE: The present multicenter randomized controlled trial compared the clinical and radiographic outcomes of an aragonite-based osteochondral implant with a control group (arthroscopic debridement/microfractures) in patients affected by joint surface lesions of the knee, including those with concurrent mild to moderate osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 251 patients were enrolled in 26 medical centers according to the following criteria: age 21 to 75 years, up to 3 cartilage defects of International Cartilage Regeneration & Joint Preservation Society grade 3a or above located on the femoral condyles and/or trochlea, total treatable area from 1 to 7 cm2, bony defect depth ≤8 mm, and knee osteoarthritis grade 0 to 3 according to Kellgren-Lawrence score. Patients were randomized to the aragonite-based implant or debridement/microfracture control arm in a 2:1 ratio. Evaluation was performed at 6, 12, 18, and 24 months based on overall Knee injury and Osteoarthritis Outcome Score (KOOS) as the primary endpoint, and the KOOS subscales (Pain, Quality of Life, Activities of Daily Living), percentage of responders, and International Knee Documentation Committee (IKDC) subjective score as the secondary endpoints. Patients also underwent magnetic resonance imaging evaluation at 12 and 24 months to assess defect fill grade. Failures (ie, need for any secondary treatment) and adverse events were also recorded. RESULTS: The implant group showed a statistically superior outcome in the primary endpoint and all secondary endpoints at each follow-up. The magnitude of improvement in the implant group was twice as large as that in the control group in terms of mean KOOS improvement at 2 years. Responder rate (defined as at least a 30-point improvement in overall KOOS) was 77.8% in the implant group as opposed to 33.6% in the control (P < .0001). Statistically superior results were seen in the IKDC score as well. At 24 months, 88.5% of the implanted group had at least 75% defect fill on magnetic resonance imaging as compared with 30.9% of controls (P < .0001). The failure rate was 7.2% for the implant group versus 21.4% for control. CONCLUSION: This aragonite-based scaffold was safe and effective in the treatment of chondral and osteochondral lesions in the knee, including patients with mild to moderate osteoarthritis, and provided superior outcomes as compared with the control group. REGISTRATION: NCT03299959 (ClinicalTrials.gov identifier).

Harvest Technique Does Affect the Quality of Osteochondral Grafts: Histologic Evaluation Comparing Commercial Standards versus Scalpel Blade Technique.

OBJECTIVE: While the percentage of viable cells is a major determinant of graft performance during osteochondral allograft (OCA) transplantation, the baseline chondrocyte viability at the periphery of osteochondral plugs is defined at the time of harvest. In this laboratory study, we aimed to determine the optimal technique for OCA plug harvest by evaluating commercial standard techniques compared to sharp blade harvest technique. DESIGN: Osteochondral explants were harvested from bovine and human samples using 3 different techniques: (1) standard OATS manual punch device (Osteochondral Autograft Transplant System OATS; Arthrex, Naples, FL), (2) powered trephine device, and (3) fresh scalpel blade. Chondrocyte viability and the dead area at the periphery of the tissue were evaluated by LIVE/DEAD staining. Safranin-O and fast-green were performed for structural evaluation. RESULTS: For both bovine and human samples, the dead area at the periphery of the explant was significantly smaller after scalpel blade preparation compared to harvest with OATS (P < 0.001) and powered trephine devices (P < 0.001). In addition, while powered device had a smaller remaining dead area compared to the OATS device (P < 0.001), there was significantly greater tissue loss and peripheral contour change for plugs harvested with the powered trephine device. CONCLUSION: Our study demonstrated that OCA plugs harvested with OATS and powered device lead to a significant mechanical injury at the periphery of the explants compared to a scalpel. We propose that the optimal technique for OCA harvest utilizes a combined approach incorporating a scalpel blade/circular scalpel to prepare the chondral surface and a powered trephine to prepare the osseous surface.

Anteromedialization Tibial Tubercle Osteotomy Improves Patellar Contact Forces: A Cadaveric Model of Patellofemoral Dysplasia.

BACKGROUND: Patellofemoral (PF) dysplasia is common in patients with recurrent patellar instability. Tibial tubercle osteotomy (TTO) is performed with goals of correcting patellar maltracking and redistributing contact forces across the PF joint. The biomechanical effects of TTO in the setting of PF dysplasia have not been quantified. PURPOSE/HYPOTHESIS: To quantify patellar contact mechanics and kinematics after TTO in the setting of PF dysplasia. We hypothesized that a simulated anteromedialization (AMZ) TTO would improve PF contact mechanics as compared with a pure medialization TTO. STUDY DESIGN: Controlled laboratory study. METHODS: PF dysplasia with Dejour type D classification was simulated in 7 cadaveric knees by replacing the native patellar and trochlear surfaces with synthetic polymeric patellar and trochlear implants. On each specimen, a flat TTO was fixed in 3 distinct positions simulating a pathologic lateralized tubercle (pathologic condition), a medialized tubercle (Elmslie Trillat), and an AMZ tubercle. The sum of forces acting on the medial and lateral patellar facet and patellar kinematics was computed for each knee for each condition from 0° to 70° of flexion at 10° increments. RESULTS: Relative to the pathologic condition, AMZ TTO decreased contact forces across the lateral facet (20°-50° and 70° of flexion). Relative to the pathologic condition, Elmslie Trillat TTO had no effect on contact forces on either compartment. Relative to the Elmslie Trillat TTO, the AMZ TTO had significantly decreased contact forces across the medial facet (at 40°, 60°, and 70° of flexion). No significant differences in joint kinematics occurred across any groups. CONCLUSION: Of all groups studied, AMZ TTO resulted in significantly decreased patellar contact forces in simulated dysplastic PF joints. AMZ may be considered in certain patients with PF dysplasia to avoid medial compartment PF chondral overload. CLINICAL RELEVANCE: PF dysplasia is common in patients with recurrent patellar instability who warrant surgical intervention to prevent subsequent recurrence. Numerous interventions to treat this condition, including various TTOs, have been proposed without a clear consensus. This cadaveric biomechanical study demonstrates that AMZ TTO resulted in more favorable PF contact mechanics than Elmslie Trillat TTO in a model representing PF dysplasia. AMZ TTO may be considered for patients in the setting of recurrent instability with PF dysplasia to avoid cartilage overload on the medial compartment of the PF joint.

An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months.

PURPOSE: The purpose of this crossover study was to determine the efficacy of amniotic suspension allograft (ASA) for moderate symptomatic knee osteoarthritis following failed treatment with hyaluronic acid (HA) or saline through 12 months' postcrossover injection using patient-reported and safety outcomes. METHODS: In this multicenter study, 95 patients from a 200-patient single-blind randomized controlled trial were eligible to crossover and receive a single injection of ASA 3 months after failed treatment with HA or saline. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS), were collected out to 12 months postcrossover to determine pain and function. Radiographs and blood were collected for assessment of changes. Statistical analyses were performed using mixed effects model for repeated measures. RESULTS: Treatment with ASA following failed treatment with HA or saline resulted in significant improvements in KOOS and VAS scores compared with crossover baseline. There were no differences in radiographic measures or anti-human leukocyte antigen serum levels compared with baseline and no severe adverse events reported. In addition, more than 55% of patients were responders at months 3, 6, and 12 as measured by the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified responder criteria. There were no significant differences between the original ASA randomized group and crossover cohorts at any of the time points evaluated, suggesting that prior failed treatment with HA or saline did not significantly impact outcomes following treatment with ASA. CONCLUSIONS: This study showed that patients who previously failed treatment with HA or saline had statistically significant improvements in pain and function scores following a crossover injection of ASA that was sustained for 12 months, as measured by KOOS and VAS. There were no serious adverse events reported, and the injection was safe. LEVEL OF EVIDENCE: II, prospective cohort study.

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.