Factors Influencing Long-term Outcomes After Matrix-Induced Autologous Chondrocyte Implantation: Long-term Results at 10 Years.

BACKGROUND: Matrix-induced autologous chondrocyte implantation (MACI), the third-generation of the technique, is an established procedure for the treatment of focal cartilage defects in the knee. However, the literature lacks long-term results of MACI with good statistical power. PURPOSE: To determine long-term survival and patient-reported outcomes (PROs) in a representative cohort and to identify patient- and surgery-related parameters that may influence long-term clinical outcomes. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 103 patients were clinically evaluated at the current follow-up of 8.1 years (range, 5-11.9 years). PRO measures (PROMs) included the Knee injury and Osteoarthritis Outcome Score (KOOS), EQ-5D, visual analog scale for pain, and Tegner Activity Scale. Magnetic resonance imaging results were evaluated by using the AMADEUS (area measurement and depth and underlying structures) and MOCART (magnetic resonance observation of cartilage repair tissue) 2.0 knee score classification systems. Potential factors influencing PROs were first identified univariately and investigated in a multivariate regression model. RESULTS: The defects had a mean size of 4.8 cm2 (range, 1.2-12 cm2) and were predominantly femorotibial (66%). The mean Kaplan-Meier survival rate of revision for any reason was 97.2% 6 1.6% at 10 years. In comparison to preoperative values, all PROMs were significantly improved at the current follow-up (P < .05). The MOCART 2.0 score peaked at 12 months (mean, 80.2 6 15.3 months) and showed no significant change at 96 months (mean, 76.1 ± 19.5 months; P = .142). The linear multivariate regression model identified an association of body mass index (BMI), MOCART 2.0 score, and number of previous knee surgeries with KOOS (R2 = 0.41; f2 = 0.69). Further analysis of the individual determinants revealed an optimal BMI range of 20 to 29 for favorable PROs at 96 months. Significant correlations of MOCART subscores with the overall KOOS were found for graft surface and structure, bony reaction, and subchondral detectable changes. Only 30% of patients with 2 previous surgeries and 20% of patients with 3 previous surgeries achieved a Patient Acceptable Symptom State (χ2 = 10.93; P = .012). CONCLUSION: The present study shows consistently good long-term clinical outcomes after MACI with a low revision rate and high patient satisfaction. BMI and number of previous knee surgeries may influence clinical outcomes and should be considered in patient selection and education. There is a correlation between graft structure, subchondral bone changes on magnetic resonance imaging, and long-term PROMs.

Secondary matrix-associated autologous chondrocyte implantation after failed cartilage repair shows superior results when combined with autologous bone grafting: Findings from the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: The aim of this study was to evaluate whether additive autologous bone grafting (ABG) improves clinical outcome and survival in revision matrix-associated autologous chondrocyte implantation (M-ACI) after failed cartilage repair (CR). METHODS: A retrospective, registry-based, matched-pair analysis was performed to compare patient-reported outcomes and survival in secondary M-ACI with or without additional bone grafting for focal full-thickness cartilage defects of the knee and to compare it with those in primary M-ACI. Patients were matched for age, sex, body mass index, defect size and localization, and number of previous CRs. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was assessed over a follow-up period of 36 months. The patient acceptable symptomatic state, the clinical response rate and the survival of the subgroups were determined. RESULTS: A total of 818 patients were matched. Revision M-ACI (n = 238) with concomitant bone grafting was associated with significantly higher PRO as measured by KOOS (80.8 ± 16.8 vs. 72.0 ± 17.5, p = 0.032) and higher CRR (81.4% vs. 52.0%, p = 0.018) at 36 months compared to patients with revision M-ACI alone. KOOS and KOOS improvement in these patients did not differ from those who underwent primary M-ACI (p = n.s.). The combination of M-ACI and ABG resulted in a significantly higher KOOS at 36 months than M-ACI alone, regardless of whether bone marrow stimulation (89.6 ± 12.5 vs. 68.1 ± 17.9, p = 0.003) or ACI (82.6 ± 17.0 vs. 72.8 ± 16.0, p = 0.021) was performed before. Additional bone grafting results in equivalent survival rates at 7 years in secondary compared to primary M-ACI (83% vs. 84%, p = n.s.). CONCLUSIONS: Regardless of the type of previous CR, additional bone grafting in secondary M-ACI improves the clinical outcome, response rate and survival at 36 months compared to M-ACI alone. Secondary M-ACI with ABG had comparable clinical response and survival rates to primary M-ACI. Therefore, subchondral bone should be treated even in cases of mild bone involvement in revision M-ACI. LEVEL OF EVIDENCE: Level III.

Favourable clinical outcomes and low revision rate after M-ACI in adolescents with immature cartilage compared to adult controls: Results at 10 years.

PURPOSE: The purpose of this study was to evaluate long-term survival, patient-reported outcomes (PROs) and radiographic results of matrix-associated autologous chondrocyte implantation (M-ACI) in adolescents with immature cartilage and compare them to adult controls. METHODS: A retrospective matched-pair analysis was performed comparing the PRO after M-ACI for focal cartilage defect of the knee in cartilaginous immature adolescents to mature adults. Groups were matched for sex, body mass index, defect site and size, symptom duration and the number of previous knee surgeries. Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART 2.0) scores were assessed at least 60 months postoperatively. Patient acceptable symptomatic state (PASS) and clinical response rate in KOOS and KOOS subscores were calculated. RESULTS: A total of 54 patients were matched. At a mean of 96 months (65-144 months), no surgical complications, graft hypertrophy or reoperations were noted in the cohorts studied. Adolescents showed superior PROs at the final follow-up (76.9 ± 14.1 vs. 66.4 ± 15.0, p = 0.03) and were significantly more likely to achieve PASS (74.1% vs. 55.6%; p = 0.02) compared to the adult cohort. The KOOS subscale analysis showed long-term benefits for adolescents in terms of symptom improvement, pain reduction, activities of daily living, sports and quality of life (p < 0.05). None of the patients in the adolescent group showed graft hypertrophy on magnet resonance imaging or signs of osteoarthritis on radiographs at long-term follow-ups. CONCLUSIONS: M-ACI is an effective treatment for chondral defects of the knee in patients with immature cartilage with low revision rates and high patient satisfaction over the long term. Adolescents showed comparable clinical and radiographic results in the short and medium term, with slightly more favourable, clinically relevant functional results in adolescents in the long term. M-ACI can be safely used in adolescents, and consideration should be given to expanding the indication to include these patients. LEVEL OF EVIDENCE: Level III.

Neutral to slightly undercorrected mechanical leg alignment provides superior long-term results in patients undergoing matrix-associated autologous chondrocyte implantation.

PURPOSE: The aim of this study was to evaluate the role of leg alignment on long-term clinical outcome after matrix-associated autologous chondrocyte implantation (M-ACI) and to define an individualized target range to optimize clinical outcome. METHODS: The present study examined patients who underwent M-ACI of the femoral condyle. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) were used to assess the results. Clinical outcomes were related to Patient Acceptable Symptomatic State (PASS). For intra- and interobserver reliability of mechanical tibiofemoral angle, mechanical medial proximal tibial angle and mechanical lateral distal femoral angle, we calculated intraclass correlation coefficients using a two-way mixed model with absolute agreement. A regression model and receiver-operating characteristics curve were used to identify an individual range of alignment where a favourable clinical outcome could be expected in the long term. RESULTS: Additional osteotomy was performed in 50% of patients with similar clinical outcomes as physiologically aligned patients (p > 0.05). The curve-fitting regression model identified a target range of -2.5° valgus to 4.5° varus for ideal postoperative alignment (R2 = 0.12, p = 0.01). Patients within this range were more likely to achieve PASS (70% vs. 27%, p = 0.001). In medially treated defects, a refined range of -2.5° valgus to 4° varus alignment was found (R2 = 0.15, p = 0.01). These patients were more likely to achieve PASS (67% vs. 30%, p = 0.01) and showed favourable postoperative KOOS and MOCART scores (p = 0.02). Patients with lateral defects were more likely to achieve PASS within a range of -2° valgus and 0.5° varus (90% vs. 45%, p = 0.03) and showed favourable postoperative KOOS and MOCART scores (p = not significant). CONCLUSIONS: An individual range of leg alignment-whether achieved by osteotomy or physiologic alignment-should be respected in M-ACI treatment. A neutral to slightly undercorrected alignment favours the postoperative outcome after M-ACI. When planning surgery for patients with focal cartilage defects of the femoral condyle, these ranges should be recognized as critical factors. LEVEL OF EVIDENCE: Level III.

The role of autologous bone grafting in matrix-associated autologous chondrocyte implantation at the knee: Results from the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: To investigate whether concomitant autologous bone grafting adversely affects clinical outcome and graft survival after matrix-associated autologous chondrocyte implantation (M-ACI). METHODS: The present study examines registry data of patients who underwent M-ACI with or without autologous bone grafting for large-sized chondral or osteochondral defects. Propensity score matching was performed to exclude potential confounders. A total of 215 patients with similar baseline characteristics were identified. Clinical outcome was assessed at the time of surgery and at 6, 12, 24, 36 and 60 months using the Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS change, clinical response rate, KOOS subcomponents and failure rate were determined. RESULTS: Patients treated with M-ACI and autologous bone grafting achieved comparable clinical outcomes compared with M-ACI alone. At 24 months postoperatively, the patient-reported outcome (PRO) of patients treated with M-ACI and autologous bone grafting was even significantly better as measured by KOOS (74.9 ± 18.8 vs. 79.2 ± 15.4; p = 0.043). However, the difference did not exceed the minimal clinically important difference (MCID). In patients with M-ACI and autologous bone grafting, a greater change in KOOS relative to baseline was observed at 6 (9.3 ± 14.7 vs. 15.0 ± 14.7; p = 0.004) and 12 months (12.6 ± 17.2 vs. 17.7 ± 14.6; p = 0.035). Overall, a high clinical response rate was observed in both groups at 24 months (75.8% vs. 82.0%; p = n.s.). The estimated survival at the endpoint of reoperation for any reason was 82.1% (SD 2.8) at 8.4 years for isolated M-ACI and 88.7% (SD 2.4) at 8.2 years for M-ACI with autologous bone grafting (p = 0.039). CONCLUSIONS: Even in the challenging cohort of large osteochondral defects, the additional treatment with autologous bone grafting leads to remarkably good clinical outcomes in patients treated with M-ACI. In fact, they tend to benefit more from surgery, have lower revision rates and achieve clinical response rates earlier. Subchondral bone management is critical to the success of M-ACI and should be addressed in the treatment of borderline defects. LEVEL OF EVIDENCE: Level III.

[The first decade of the DGOU's cartilage register-insights for clinical practice]. / Die erste Dekade des KnorpelRegisters der DGOU ­ Erkenntnisse für die klinische Praxis.

BACKGROUND: Registry data provide valuable epidemiological insights that help to further improve process and outcome quality in patient care. The German Cartilage Registry (KnorpelRegister DGOU) was established in 2013 as an instrument for quality assurance after surgical cartilage regenerative procedures on hip, knee and ankle joints. DATA COLLECTION: Participation in the German Cartilage Registry is optional for hospitals and practices. Currently, more than 160 institutions in Germany, Austria and Switzerland participate in the data collection. DATA COLLECTED AND INITIAL FINDINGS: The implementation of PROMs ("patient related outcome measurement"), as well as the recording of surgery-related influencing factors, enable a differentiated scientific analysis and represent a key quality feature of the registry. Initial analyses of the registry data have already provided clinically relevant findings for immediate patient care. For example, patients who underwent focal cartilage therapy prior to ACT show a clinically relevant, significantly worse outcome than patients who underwent primary ACT. First conclusions could also be drawn regarding the relevance of concomitant cartilage therapy. For example, in patients with focal cartilage damage of the medial knee joint compartment, registry data indicate that leg axis correction is indicated even in cases of mild deviation of the mechanical leg axis. CONCLUSION: The data and findings obtained from the Cartilage Registry represent an important aspect of clinical care research and serve as a complement to well-designed, clinically prospective cohort studies, RCTs, and meta-analyses.

How is hip anatomy reconstruction and inlay wear associated up to 10 years after primary THA using ceramic on highly crosslinked polyethylene bearings?

INTRODUCTION: Conventional polyethylene (PE) wear has been reported to be associated with femoral offset reconstruction and cup orientation after THA. Thus, the present study aimed (1) to determine the polyethylene wear rate of 32 mm ceramic heads with highly cross-linked polyethylene (HXLPE) inlays up to 10 years postoperatively and (2) to identify patient and surgery-related factors affecting the wear rate. METHODS: A prospective cohort study was performed, investigating 101 patients with 101 cementless THAs and ceramic (32 mm) on HXLPE bearings after 6-24 months, 2-5 years and 5-10 years postoperatively. The linear wear rate was determined using a validated software (PolyWare®, Rev 8, Draftware Inc, North Webster, IN, USA) by two reviewers, blinded to each other. A linear regression model was used to identify patient and surgery-related factors on HXLPE -wear. RESULTS: After an initial bedding-in phase of 1 year after surgery, the mean linear wear rate was 0.059 ± 0.031 mm/y at ten years (mean 7.7 years; SD 0.6 years, range 6-10), being below the osteolysis relevant threshold of 0.1 mm/year. The regression analysis demonstrated that age at surgery, BMI, cup inclination or anteversion and the UCLA score were not associated with the linear HXLPE-wear rate. Only increased femoral offset showed a significant correlation with an increased HXLPE-wear rate (correlation coefficient of 0.303; p = 0.003) with a moderate clinical effect size (Cohen's f²=0.11). CONCLUSION: In contrast to conventional PE inlays, hip arthroplasty surgeons may be less concerned about osteolysis-related wear of the HXLPE if the femoral offset is slightly increased. This allows focusing on joint anatomy reconstruction, hip stability and leg length.

Integrating the Combined Sagittal Index Reduces the Risk of Dislocation Following Total Hip Replacement.

BACKGROUND: The aims of this matched cohort study were to (1) assess differences in spinopelvic characteristics between patients who sustained a dislocation after total hip arthroplasty (THA) and a control group without a dislocation, (2) identify spinopelvic characteristics associated with the risk of dislocation, and (3) propose an algorithm including individual spinopelvic characteristics to define an optimized cup orientation target to minimize dislocation risk. METHODS: Fifty patients with a history of THA dislocation (29 posterior and 21 anterior dislocations) were matched for age, sex, body mass index (BMI), index diagnosis, surgical approach, and femoral head size with 200 controls. All patients underwent detailed quasi-static radiographic evaluations of the coronal (offset, center of rotation, and cup inclination/anteversion) and sagittal (pelvic tilt [PT], sacral slope [SS], pelvic incidence [PI], lumbar lordosis [LL], pelvic-femoral angle [PFA], and cup anteinclination [AI]) reconstructions. The spinopelvic balance (PI - LL), combined sagittal index (CSI = PFA + cup AI), and Hip-User Index were determined. Parameters were compared between the control and dislocation groups (2-group analysis) and between the controls and 2 dislocation groups identified according to the direction of the dislocation (3-group analysis). Important thresholds were determined from receiver operating characteristic (ROC) curve analyses and the mean values of the control group; thresholds were expanded incrementally in conjunction with running-hypothesis tests. RESULTS: There were no coronal differences, other than cup anteversion, between groups. However, most sagittal parameters (LL, PT, CSI, PI - LL, and Hip-User Index) differed significantly. The 3 strongest predictors of instability were PI - LL >10° (sensitivity of 70% and specificity of 65% for instability regardless of direction), CSIstanding of <216° (posterior instability), and CSIstanding of >244° (anterior instability). A CSI that was not between 205° and 245° on the standing radiograph (CSIstanding) was associated with a significantly increased dislocation risk (odds ratio [OR]: 4.2; 95% confidence interval [CI]: 2.2 to 8.2; p < 0.001). In patients with an unbalanced and/or rigid lumbar spine, a CSIstanding that was not 215° to 235° was associated with a significantly increased dislocation risk (OR: 5.1; 95% CI: 1.8 to 14.9; p = 0.001). CONCLUSIONS: Spinopelvic imbalance (PI - LL >10°) determined from a preoperative standing lateral spinopelvic radiograph can be a useful screening tool, alerting surgeons that a patient is at increased dislocation risk. Measurement of the PFA preoperatively provides valuable information to determine the optimum cup orientation to aim for a CSIstanding of 205° to 245°, which is associated with a reduced dislocation risk. For patients at increased dislocation risk due to spinopelvic imbalance (PI - LL >10°), the range for the optimum CSI is narrower. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Fifty-six percent of proximal femoral cortical hypertrophies 6 to 10 years after Total hip arthroplasty with a short Cementless curved hip stem - a cause for concern?

BACKGROUND: Thigh pain and cortical hypertrophies (CH) have been reported in the short term for specific short hip stem designs. The purpose of the study was to investigate 1) the differences in clinical outcome, thigh pain and stem survival for patients with and without CHs and 2) to identify patient and surgery-related factors being associated with the development of CHs. METHODS: A consecutive series of 233 patients with 246 hips was included in the present retrospective diagnostic cohort study, who had received a total hip arthroplasty (THA) between December 2007 and 2009 with a cementless, curved, short hip stem (Fitmore, Zimmer, Warsaw, IN, USA). Clinical and radiographic follow-up, including the radiographic parameters for hip geometry reconstruction, were prospectively assessed 1, 3, and 6 to 10 years after surgery. RESULTS: Cortical hypertrophies were observed in 56% of the hips after a mean of 7.7 years, compared to 53% after 3.3 years being mostly located in Gruen zone 3 and 5. There was no significant difference for the Harris Hip Score and UCLA score for patients with and without CHs. Only one patient with a mild CH in Gruen zone 5 and extensive heterotopic ossifications around the neck of the stem reported thigh pain. The Kaplan Meier survival rate after 8.6 years was 99.6% (95%-CI; 97.1-99.9%) for stem revision due to aseptic loosening and no association with CHs could be detected. Postoperative increase in hip offset was the only risk factor being associated with the development of CHs in the regression model (ΔHO; OR 1.1 (1.0-1.2); p = 0.001). CONCLUSIONS: The percentage of cortical hypertrophies remained almost constant in the mid-term compared to the short-term with the present cementless short hip stem design. The high percentage of cortical hypertrophies seems not be a cause for concern with this specific implant in the mid-term. LEVEL OF EVIDENCE: Diagnostic Level IV.