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.

Implantable Shock Absorber Provides Superior Pain Relief and Functional Improvement Compared With High Tibial Osteotomy in Patients with Mild-to-Moderate Medial Knee Osteoarthritis: A 2-Year Report.

OBJECTIVE: Up to 10 million Americans below the age of 65 years have symptomatic knee osteoarthritis (OA) and may not yet be candidates for arthroplasty. In response, a subcutaneous implantable shock absorber (ISA) that unloads the knee has been developed. The safety and effectiveness of ISA treatment were compared against a surgical unloading control, high tibial osteotomy (HTO). DESIGN: This was a prospective open-label cohort study with a historical control arm. Subjects underwent ISA placement or HTO. The primary endpoint was a composite variable combining pain, function, specific adverse events, integrity of implant or hardware, and conversion to subsequent surgery. Pain and function outcomes (Western Ontario and McMaster Universities Arthritis Index scores) were assessed through 24 months. Adverse events were tracked. RESULTS: The primary endpoint demonstrated superiority of the ISA arm versus the HTO arm, with 85.6% of ISA subjects meeting all criteria compared with 65.5% of HTO subjects. In addition, all 5 secondary endpoints showed superiority of ISA over HTO. At 24 months, the proportions of subjects considered responders were 95.8% (ISA) versus 87.9% (HTO) for pain and 91.7% (ISA) versus 81.3% (HTO) for function. The ISA procedure was well tolerated, with 13.4 days to full weightbearing status versus 58.0 days for the HTO arm. CONCLUSIONS: Treatment with an ISA demonstrated noninferiority and superiority versus treatment with HTO in subjects aged 25-65 years who had OA of the medial knee. Treatment with ISA has high clinical benefit and is durable through at least 24 months.

Inconsistent Reporting of Preauthorization Medical Criteria for Osteochondral Allograft Transplantation Surgery.

BACKGROUND: Although osteochondral allograft (OCA) transplantation has been a standard treatment for patients with osteochondral lesions, there is a disagreement in commercial payers' medical criteria regarding the definition of medical suitability and thus authorization for OCA transplantation. The primary goal of this study was to understand where consensus between a committee of experienced cartilage restoration surgeon scientists and payer policies existed and where there was significant disagreement. METHODS: U.S. private payers were identified by reviewing health insurance market research literature. Medical criteria were then obtained from publicly available payer medical polices. A literature review was conducted to identify supporting evidence for consensus statements based on private payer medical criteria. The MOCA (Metrics of Osteochondral Allograft) Committee, 30 experienced surgeons and subject-matter experts in OCA transplantation, used a Likert scale of 1 (strongly disagree) to 5 (strongly agree) to rank each statement. The extent of agreement and disagreement among participants was measured for each statement. Consensus was defined as agreement or disagreement of >75%. RESULTS: Fifty-seven statements regarding relevant medical criteria for OCA transplantation were included in the survey. All 30 MOCA Committee members completed the survey (100% response rate). Over half of the statements (52.6%) did not reach consensus. Of the remaining 27 statements that reached consensus, respondents agreed or strongly agreed with 16 statements, and disagreed or strongly disagreed with 11 statements. Inconsistent voting was observed for statements related to osteoarthritis, inflammation, and degenerative changes. CONCLUSIONS: Commercial payers are not consistent in the medical criteria used to define patient eligibility for authorization of OCA transplantation. In contrast, an expert panel of cartilage surgeons reached a consensus that OCA transplantation was clearly suitable for a variety of specific indications. This study demonstrates the need to standardize medical criteria for cartilage restoration based on the most current literature, as well as in conjunction with experienced cartilage restoration experts. LEVEL OF EVIDENCE: Therapeutic Level V . See Instructions for Authors for a complete description of levels of evidence.

Marrow Stimulation Has Relatively Inferior Patient-Reported Outcomes in Cartilage Restoration Surgery of the Knee: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Multiple cartilage repair techniques are available for chondral defects in the knee. Optimal treatment is controversial. PURPOSE: To evaluate change from baseline in the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales among different cartilage repair techniques of the knee. STUDY DESIGN: Systematic review and meta-analysis; Level of evidence, 1A. METHODS: Medline and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for randomized controlled trials with minimum 1 year follow-up reporting change from baseline KOOS (delta KOOS) subscale values. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. A meta-analysis was performed on the following surgery types: microfracture (Mfx); augmented microfracture techniques (Mfx+Augment); and culture-based therapies, including autologous chondrocyte implantation (ACI) and matrix-assisted autologous chondrocyte implantation (MACI). A random-effects metaregression model was used. RESULTS: A total of 14 randomized trials with a total of 775 patients were included. The KOOS Sport and Recreation (Sport) and KOOS Quality of Life (QOL) were the 2 most responsive subscales after operative intervention. Outcomes from Mfx and Mfx+Augment were not different in any of the 5 KOOS subscales (minimum P > .3). The mean delta KOOS Sport after ACI/MACI was 9.9 points greater than after Mfx (P = .021) and 11.7 points greater than after Mfx+Augment (P = .027). Longer follow-up time correlated with greater delta KOOS Sport (P = .028). Larger body mass index led to greater delta KOOS QOL (P = .045). Larger cartilage defect size correlated with greater delta KOOS Pain and KOOS Activities of Daily Living scores (P = .023 and P = .002, respectively). CONCLUSION: The KOOS Sport and QOL were the most responsive subscales after cartilage restoration surgery of the knee. Culture-based therapies (ACI/MACI) led to clinically relevant improvements in the KOOS Sport score compared with marrow stimulation and may be a more appropriate treatment in younger and more active individuals. There were no benefits to Mfx+Augment over Mfx alone in any of the KOOS subscales.

Evaluation of Osseous Incorporation After Osteochondral Allograft Transplantation: Correlation of Computed Tomography Parameters With Patient-Reported Outcomes.

BACKGROUND: Studies have reported favorable clinical outcomes after osteochondral allograft (OCA) transplantation to treat osteochondral defects and have demonstrated that healing of the osseous component may be critical to outcomes. However, there is currently no consensus on the optimal modality to evaluate osseous healing. PURPOSE: To define parameters for OCA healing using computed tomography (CT) and to investigate whether osseous healing identified using CT is correlated with improved pain and function on patient-reported outcomes (PROs) collected closest in time to the postoperative CT scan and at final follow-up. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Of 118 patients who underwent OCA transplantation for articular cartilage defects of the knee over the 10-year study period, 60 were included in final analysis based on completion of CT scans at 5.8 ± 1.9 months postoperatively and PROs collected preoperatively and postoperatively. CT parameters, including osseous incorporation, bone density, subchondral bone congruency, and cystic changes, were summarized for each patient relative to the cohort. Parameters were assessed for inter- and intrarater reliability as well as for covariation with patient characteristics and surgical variables. Structural equation modeling was used to assess correlation of CT parameters with change in PROs from preoperatively to those collected closest in time to CT acquisition and at the final follow-up. RESULTS: Bone incorporation was the most reliable CT parameter. The summarized scores for CT scans were normally distributed across the study population. Variance in CT parameters was independent of age, sex, body mass index, prior surgery, number of grafts, lesion size, and location. No significant correlation (P > .12 across all comparisons) was identified for any combination of CT parameter and change in PROs from baseline for outcomes collected either closest to CT acquisition or at the final follow-up (mean, 38.2 ± 19.9 months; range, 11.6-84.9 months). There was a uniformly positive association between change in PROs and host bone density but not graft bone density, independent of patient characteristics and surgical factors. CONCLUSION: CT parameters were independent of clinical or patient variables within the study population, and osseous incorporation was the most reliable CT parameter. Metrics collected from a single postoperative CT scan was not correlated with clinical outcomes at ≥6-month longitudinal follow-up.

An Expert Consensus Statement on the Management of Large Chondral and Osteochondral Defects in the Patellofemoral Joint.

BACKGROUND: Cartilage lesions of the patellofemoral joint constitute a frequent abnormality. Patellofemoral conditions are challenging to treat because of complex biomechanics and morphology. PURPOSE: To develop a consensus statement on the functional anatomy, indications, donor graft considerations, surgical treatment, and rehabilitation for the management of large chondral and osteochondral defects in the patellofemoral joint using a modified Delphi technique. STUDY DESIGN: Consensus statement. METHODS: A working group of 4 persons generated a list of statements related to the functional anatomy, indications, donor graft considerations, surgical treatment, and rehabilitation for the management of large chondral and osteochondral defects in the patellofemoral joint to form the basis of an initial survey for rating by a group of experts. The Metrics of Osteochondral Allografts (MOCA) expert group (composed of 28 high-volume cartilage experts) was surveyed on 3 occasions to establish a consensus on the statements. In addition to assessing agreement for each included statement, experts were invited to propose additional statements for inclusion or to suggest modifications of existing statements with each round. Predefined criteria were used to refine statement lists after each survey round. Statements reaching a consensus in round 3 were included within the final consensus document. RESULTS: A total of 28 experts (100% response rate) completed 3 rounds of surveys. After 3 rounds, 36 statements achieved a consensus, with over 75% agreement and less than 20% disagreement. A consensus was reached in 100.00% of the statements relating to functional anatomy of the patellofemoral joint, 88.24% relating to surgical indications, 100.00% relating to surgical technical aspects, and 100.00% relating to rehabilitation, with an overall consensus of 95.5%. CONCLUSION: This study established a strong expert consensus document relating to the functional anatomy, surgical indications, donor graft considerations for osteochondral allografts, surgical technical aspects, and rehabilitation concepts for the management of large chondral and osteochondral defects in the patellofemoral joint. Further research is required to clinically validate the established consensus statements and better understand the precise indications for surgery as well as which techniques and graft processing/preparation methods should be used based on patient- and lesion-specific factors.

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.

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.

Efficacy of Fresh Osteochondral Allograft Transplantation in the Knee for Adults 40 Years and Older.

BACKGROUND: Osteochondral allograft (OCA) transplantation has become a standard therapy for cartilage restoration in young patients. PURPOSE: To determine the efficacy of fresh OCA transplantation for focal cartilage lesions in patients aged ≥40 years compared with a group of patients aged ≤39 years. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A database was used to identify patients who underwent fresh OCA transplantation in the knee in a single-surgeon practice over a 10-year period and who completed baseline patient-reported outcome (PRO) questionnaires, including the International Knee Documentation Committee (IKDC); Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of Pain, Symptoms, Activities of Daily Living, Quality of Life (QOL), and Sports & Recreation; and Veterans RAND 12-Item Health Survey (VR-12). Patients who completed the same PRO measures at a minimum 12-month follow-up were categorized into 2 groups based on age at surgery and were observed longitudinally. Mixed-model regression was used to predict longitudinal growth curves for each PRO score while controlling for confounding patient and surgical variables. RESULTS: The study group consisted of 38 patients with a mean age of 52.32 years (range, 40-69 years) and mean final follow-up of 44.47 ± 24.32 months. The control group consisted of 42 patients with a mean age of 27.19 years (range, 15-39 years) and mean final follow-up of 33.75 ± 19.53 months. A statistically significant improvement from baseline to final follow-up was seen for the IKDC score and all 5 KOOS subscores in both the study and the control groups (P < .01 in 10 of 12 comparisons and P < .05 for the other 2 comparisons). Maximum improvements were seen in the KOOS QOL and Sports & Recreation subscores for both groups. There was no statistically significant difference between groups in the change from baseline to final follow-up or in differences at any time point in model-based longitudinal projections for any PRO score through 5 years. CONCLUSION: There was a significant improvement of outcomes for both groups, with no statistically significant difference between groups over longitudinal follow-up. The efficacy of fresh OCA transplantation in adults aged ≥40 years with a focal chondral lesion and without osteoarthritis is similar to that of younger adults, and benefits are greatest for the KOOS QOL and Sports & Recreation subscales, which reflect functional outcomes.

A Unique Case of Common Peroneal Nerve Entrapment.

The authors present a case of a previously healthy 36-year-old man with a 3-day history of spontaneous complete right lower extremity foot drop. He noticed the symptoms immediately when he attempted to stand after waking from sleep. The patient had no history of similar symptoms, recent trauma, or peripheral nerve disease. Physical examination showed a slap foot gait, complete numbness of the lateral leg and dorsal foot, and 0/5 strength with ankle and great toe dorsiflexion and ankle eversion. Serum laboratory studies showed normal values. Nerve conduction studies confirmed increased latency and decreased amplitude of the right peroneal nerve at the knee, whereas electromyography showed denervation of the tibialis anterior and extensor digitorum brevis. Anteroposterior and lateral radiographs showed a normal right knee with the exception of a posterior fibular neck exostosis. Physical therapy, an ankle-foot orthosis, and a 5-day course of oral prednisone burst (50 mg) were prescribed. After 1 month of therapy without resolution, the patient underwent surgical release of the common peroneal nerve and excision of the bony prominence. Twelve days postoperatively, the patient had no sensory improvements but had improved findings on motor examination. Three months postoperatively, the patient had near-normal sensation to light touch in the superficial and deep peroneal nerves, with 5/5 strength and a normal gait. The patient returned to all activity without limitations. The authors present this unique case describing a fibro-osseous source of common peroneal compressive neuropathy and review the literature for spontaneous peroneal entrapment, highlighting the importance of prompt diagnosis and treatment.

Clinical and Cost Implications of Inpatient Versus Outpatient Orthopedic Surgeries: A Systematic Review of the Published Literature.

The number of outpatient orthopedic surgeries performed within North America continues to increase. The impact of this change in services on patient outcomes is largely unknown. The objective of this review is to compare patient outcomes and associated costs for outpatient orthopedic surgeries traditionally performed in hospital to inpatient surgeries, as well as to summarize the eligibility and preoperative education requirements for outpatient orthopedic surgery in North America. We performed a systematic review of Medline, Pubmed and Embase databases for articles comparing the clinical and economic impact of outpatient orthopedic surgical procedures versus inpatient procedures in North America. We reported on requirements for inpatient versus outpatient care, preoperative education requirements, complications and patient outcomes, patient satisfaction, and when available total mean costs. Nine studies met the inclusion criteria for this review. Eligibility requirements for outpatient orthopedic surgery within the included studies varied, but generally included: patient consent, a caregiver at home following surgery, close proximity to an outpatient center, and no history of serious medical problems. Preoperative education programs were not always compulsory and practices varied between outpatient centers. All of the reviewed studies reported that outpatient surgeries had similar or improved level of pain and rates of nausea. Outpatients reported increased satisfaction with the care they received. As expected, outpatient procedures were less expensive than inpatient procedures. This review found that outpatient procedures in North America appear to be less expensive and safe alternatives to inpatient care for patients who are at lower risk for complications and procedures that do not necessarily require close hospital level care monitoring following same day surgery.

Temporal in vivo assessment of fresh osteochondral allograft transplants to the distal aspect of the femur by dGEMRIC (delayed gadolinium-enhanced MRI of cartilage) and zonal T2 mapping MRI.

BACKGROUND: Zonal T2 mapping and dGEMRIC (delayed gadolinium-enhanced magnetic resonance imaging of cartilage) are diagnostic quantitative techniques to evaluate the biochemical health of articular cartilage. We adapted these techniques to investigate the results of osteochondral allograft transplantation and correlated the findings with patient-reported outcomes. METHODS: Nine patients with contained ICRS (International Cartilage Repair Society) grade-4 defects of the articular portion of a femoral condyle were treated with fresh osteochondral allografts and were evaluated prospectively with dGEMRIC and T2 mapping before and after gadolinium administration. The KOOS (Knee Injury Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) subjective scores were obtained at baseline and at one and two years postoperatively. For quantitative T2 mapping, regions of interest were drawn in the deep and superficial layers of allograft and control cartilage. For dGEMRIC analyses, the relaxation rate, post-gadolinium change in relaxation rate, and ratio between changes in the allograft and control regions of interest were calculated from T1 values. RESULTS: The mean ratio between the post-gadolinium changes in the allograft and control cartilage was 1.13 at one year and 1.55 at two years, and the ratio increased in eight of nine patients from one to two years. There was no difference between the mean T2 values in the deep zone of the allograft and control cartilage at one or two years (p > 0.05), but mean T2 values were higher in the superficial zone of the allograft cartilage at one (p < 0.0001) and two (p < 0.028) years. The mean improvement from baseline was significant at one and two years for the IKDC and all five KOOS subdomains (p < 0.05). All or nearly all patients showed improvements in all clinical outcomes scores at one year. CONCLUSIONS: Functional MRI techniques can be applied to noninvasively assess the biochemical health of cartilage after osteochondral allograft transplantation. The MRI findings correlated with certain patient-reported outcomes in the early postoperative period. Relative glycosaminoglycan content and the collagen structure of allograft cartilage may undergo time-dependent degeneration. A patient's perception of clinical outcome and quality of life is likely multifactorial and is impacted by more than the health of the allograft cartilage.

Knee Function Assessment in Patients With Meniscus Injury: A Preliminary Study of Reproducibility, Response to Treatment, and Correlation With Patient-Reported Questionnaire Outcomes.

BACKGROUND: Outcomes of meniscus surgery are typically assessed with patient questionnaires that help capture symptoms and functional limitations but may not provide an accurate representation of underlying joint health. There are currently no performance-based measures of knee function in patients with symptomatic meniscus injury. PURPOSE: To assess the reproducibility, response to partial meniscectomy, and correlation with patient-reported questionnaire outcomes of novel performance-based knee function tests. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: A battery of 9 tests for activities that require knee movements essential for everyday living was developed. Intra- and interrater reproducibility was assessed in 50 meniscus tear patients completing the battery at 2 preoperative assessments with either the same or different examiners. Response to arthroscopic partial meniscectomy was evaluated in 35 of these patients 6 weeks after surgery. Subjects also completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) questionnaires pre- and postoperatively. RESULTS: The intrarater intraclass correlation coefficients (ICCs) were excellent for all tests (ICC > 0.8). Interrater ICC > 0.8 was observed for step-down, stair descent, star lunges, and timed treadmill travel. Performance on all tests improved significantly with surgery (P < .05), with the greatest improvement in sit-to-stand and stair ascent and descent. A greater percentage response to surgery was seen on questionnaire outcomes (20%-65%) than on performance-based tests (3%-15%). Moderate to poor correlations existed between the KOOS activities of daily living subscale and the performance-based tests (all ICCs ≤ 0.4). CONCLUSION: Performance-based knee function tests demonstrated good reproducibility and responsiveness in patients undergoing partial meniscectomy. CLINICAL RELEVANCE: As both patient perception and functional performance are determinants of patient outcomes, questionnaires and performance-based tests could be used simultaneously to provide complementary data to monitor short- and long-term outcomes after meniscus surgery.

Post-operative complications following primary ACL reconstruction using allogenic and autogenic soft tissue grafts: increased relative morbidity risk is associated with increased graft diameter.

BACKGROUND: The purpose of this study is to compare the risk of peri-operative complication events associated with allogenic and autogenic grafts during routine follow-up for six months after primary arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. METHODS: A retrospective cohort study identified patients that underwent ACL reconstruction via an arthroscopically assisted single tunnel technique. Fixation was primarily cortical suspension (endobutton) from the femora and bicortical fixation (Washer-loc) in the tibia. Patients were monitored for six months following surgery. Morbidity was defined as complications during this period requiring medical or surgical intervention. Risk of complications was compared according to tissue type and patient characteristics. The Cochran-Mantel-Haenszel method was applied to estimate risk ratios (RR) and confidence intervals (CI) as the measure of association between graft type and morbidity risk. RESULTS: The cohort included 413 eligible patients. Sixty six percent received allograft tissue, while the remainder received autograft tissue. Morbidity risk was 7.0% among patients receiving allograft tissue and 2.8% among patients receiving autograft tissue. Allograft demonstrated elevated risk of complication versus autograft (RR=2.3 (95% CI: 0.9-7.2)), though the data are of borderline significance (p=0.11). Complications were associated with larger graft diameter in comparison to patients who experienced no complication (9.0+/-1.2 mm v. 8.4+/-1.0mm, p=0.005). CONCLUSION: The relative morbidity risk was about two-fold greater among patients receiving allograft tissue. Regardless of tissue type, graft size was larger among patients who experienced a complication. LEVEL OF EVIDENCE: Level III.

In vivo MRI of fresh stored osteochondral allograft transplantation with delayed gadolinium-enhanced MRI of cartilage: protocol considerations and recommendations.

The protocol for delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) was adapted for the evaluation of transplanted osteochondral allograft cartilage. Eight patients with focal grade 4 cartilage defects of the femoral condyle were treated with single cylindrical osteochondral allografts. At 1 and 2 years, dGEMRIC image sequences were acquired and regions of interest (ROIs) were drawn in repair and native control cartilage. Mean T1 values of region of interest were used to calculate established dGEMRIC metrics. The correlation was measured between the ΔR1 and R1 -Post metrics for repair and native cartilage. T1 times were measured in deep and superficial zones of cartilage. A strong correlation was identified between full-thickness, deep, and superficial ΔR1 and R1 -Post values for native cartilage and repair cartilage for all years (range: 0.893-1.0). The mean T1 times and ΔR1 rate between deep and superficial regions of articular cartilage were statistically different for all regions of the distal femora analyzed at 1 year and 2 years after osteochondral allograft transplantation (P<0.05). The dGEMRIC pre-Gadolinium scan is unnecessary when evaluating transplanted osteochondral allograft cartilage. The observation of stratified T1 and ΔR1 values indicates a need to re-evaluate the methodology behind the placement of region of interest in dGEMRIC.

NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years.

BACKGROUND: Despite introduction of autologous chondrocyte therapy for repair of hyaline articular cartilage injury in 1994, microfracture remains a primary standard of care. NeoCart, an autologous cartilage tissue implant, was compared with microfracture in a multisite prospective, randomized trial of a tissue-engineered bioimplant for treating articular cartilage injuries in the knee. METHODS: Thirty patients were randomized at a ratio of two to one (two were treated with an autologous cartilage tissue implant [NeoCart] for each patient treated with microfracture) at the time of arthroscopic confirmation of an International Cartilage Repair Society (ICRS) grade-III lesion(s). Microfracture or cartilage biopsy was performed. NeoCart, produced by seeding a type-I collagen matrix scaffold with autogenous chondrocytes and bioreactor treatment, was implanted six weeks following arthroscopic cartilage biopsy. Standard evaluations were performed with validated clinical outcomes measures. RESULTS: Three, six, twelve, and twenty-four-month data are reported. The mean duration of follow-up (and standard deviation) was 26 ± 2 months. There were twenty-one patients in the NeoCart group and nine in the microfracture group. The mean age (40 ± 9 years), body mass index (BMI) (28 ± 4 kg/m2), duration between the first symptoms and treatment (3 ± 5 years), and lesion size (287 ± 138 mm2 in the NeoCart group and 252 ± 135 mm2 in the microfracture group) were similar between the groups. Adverse event rates per procedure did not differ between the treatment arms. The scores on the Short Form-36 (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) scale, and International Knee Documentation Committee (IKDC) form improved from baseline (p < 0.05) to two years postoperatively in both treatment groups. In the NeoCart group, improvement, compared with baseline, was significant (p < 0.05) for all measures at six, twelve, and twenty-four months. Improvement in the NeoCart group was significantly greater (p < 0.05) than that in the microfracture group for the KOOS pain score at six, twelve, and twenty-four months; the KOOS symptom score at six months; the IKDC, KOOS sports, and visual analog scale (VAS) pain scores at twelve and twenty-four months; and the KOOS quality of life (QOL) score at twenty-four months. Analysis of covariance (ANCOVA) at one year indicated that the change in the KOOS pain (p = 0.016) and IKDC (p = 0.028) scores from pretreatment levels favored the NeoCart group. Significantly more NeoCart-treated patients (p = 0.0125) had responded to therapy (were therapeutic responders) at six months (43% versus 25% in the microfracture group) and twelve months (76% versus 22% in the microfracture group). This trend continued, as the proportion of NeoCart-treated patients (fifteen of nineteen) who were therapeutic responders at twenty-four months was greater than the proportion of microfracture-treated participants (four of nine) who were therapeutic responders at that time. CONCLUSIONS: This randomized study suggests that the safety of autologous cartilage tissue implantation, with use of the NeoCart technique, is similar to that of microfracture surgery and is associated with greater clinical efficacy at two years after treatment.

An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years.

BACKGROUND: The healing potential of damaged articular cartilage is limited. The NeoCart is a tissue-engineered collagen matrix seeded with autogenous chondrocytes designed for the repair of hyaline articular cartilage. HYPOTHESIS: The NeoCart implant is well tolerated in the human knee. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Eight patients (treatment group) with full-thickness cartilage injury were treated with the NeoCart and evaluated prospectively. Autogenous chondrocytes provided by arthroscopic biopsy were seeded into a 3-dimensional type I collagen scaffold. The seeded scaffold was subjected to a tissue-engineering protocol including treatment with a bioreactor. Implantation of the prepared cartilage tissue patch was performed via miniarthrotomy and secured with a collagen bioadhesive. Evaluations through 24 months postoperatively included the subjective International Knee Documentation Committee questionnaire, visual analog scale, range of motion, and cartilage-sensitive magnetic resonance imaging (MRI), including quantitative T2 mapping. RESULTS: Pain scores after NeoCart implantation were significantly lower than baseline at 12 and 24 months after the procedure (P < .05). Improved function and motion were also noted at 24 months. Six patients had 67% to 100% defect fill at 24 months with MRI evaluation. One patient had moderate (33%-66%) defect fill, and another patient had poor (less than 33%) defect fill. Partial stratification of T2 values was observed for 2 patients at 12 months and 4 patients at 24 months. No patients experienced arthrofibrosis or implant hypertrophy. CONCLUSION: Pain was significantly reduced 12 and 24 months after NeoCart treatment. Trends toward improved function and motion were observed 24 months after implantation. The MRI indicated implant stability and peripheral integration, defect fill without overgrowth, progressive maturation, and more organized cartilage formation.

Subtalar release in clubfeet: a retrospective study of 10-year outcomes.

BACKGROUND: Optimal management of congenital talipes equinovarus continues to be controversial. There is a dramatically renewed emphasis on non-operative management partly because there has been a high recurrence rate among operated feet. Our hypothesis is that early, extensive subtalar ligament release as the cornerstone of aggressive hindfoot realignment prevents recurrence and retains mobility. MATERIALS AND METHODS: Twenty-two congenital clubfeet (14 patients) corrected by one surgeon were evaluated using two validated patient-based outcome instruments, dynamic pedobarographic analysis, hindfoot mobility, and weightbearing radiographs. Pedobarographic analysis consisted of quantifying peak plantar forces and pressures during the gait cycle in 22 corrected feet and 24 control feet using the FSCAN in-shoe device. RESULTS: The mean age at surgery was 8 months and mean followup was 10 years. No patients experienced recurrence of deformity. Reported foot function and satisfaction were very high for all patients and were comparable to reported normal population values. AP and lateral talocalcaneal angles for each foot were within normal limits for age. Hindfoot range of motion, including dorsiflexion, was preserved in all feet. Peak regional forces throughout the gait cycle and plantar pressures at foot flat were mildly, but statistically significantly, higher in the midfoot of corrected feet suggesting slight flattening of the arch. One patient had tendon transfers for bilateral calcaneal deformity and one patient had surgical correction of a bilateral valgus deformity. CONCLUSION: Aggressive hindfoot realignment provides definitive treatment of an equinovarus deformity, but care must be taken to avoid overcorrection.