Both Labral Debridement and Labral Repair Result in >90% Total Hip Arthroplasty-free Survival at 5-Year Follow-Up: An Analysis of the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: To compare clinical outcome parameters between labral debridement and repair by analyzing the dataset of a multinational registry. METHODS: The data are based on the hip module of the German Cartilage Registry (KnorpelRegister DGOU). The register included patients designated for cartilage or femoroacetabular impingement surgery (up to July 1, 2021; n = 2725). The assessment consisted of the patient's characteristics, the type of labral treatment, the length of labral therapy, the pathology, the grade of cartilage damage, and the type of performed approach. The clinical outcomes were documented by the international hip outcome tool via an online platform. Separated Kaplan-Meier analyses were used for total hip arthroplasty (THA)-free survival rates. RESULTS: The debridement group (n = 673) showed a mean score increase of 21.9 ± 25.3 points. The repair group (n = 963) had a mean improvement of 21.3 ± 24.6 (P > .05). The 60-month THA-free survival rate was 90% to 93% for both groups (P > .05). A multivariance analysis showed that the grade of cartilage damage was the only independent statistically significant factor (P = .002-.001) influencing patients' outcomes and THA-free survival. CONCLUSIONS: Labral debridement and repair led to good and reliable results. However, these results should not be interpreted with the conclusion that the cheaper and technically easier labral debridement is the recommended treatment due to comparable results in the present study. The clinical outcome and the THA-free survival seemed to be more influenced by the grade of cartilage damage. LEVEL OF EVIDENCE: Level III, retrospective comparative therapeutic trial.

Save the subchondral bone plate: Debridement versus bone marrow stimulation in acetabular cartilage defects over 60 months of follow-up.

PURPOSE: Bone marrow stimulation is a common treatment for full-thickness cartilage defects in the hip joint. However, common procedures may result in poor fibrous repair tissue and changes to the subchondral anatomy. This study investigated the clinical outcome of a cohort of International Cartilage Repair Society (ICRS) grades 3 and 4 cartilage defects treated with bone marrow stimulation compared to those who received simple debridement/chondroplasty. METHODS: In this retrospective registry study, 236 patients with uni-focal acetabular chondral lesions of the hip up to 400 mm² (mean 177.4 ± 113.4 mm²) and of ICRS grade ≥3 with follow-up of at least 12 months (mean 33.2 ± 15.3 months) were included. Eighty-one patients underwent bone marrow stimulation (microfracture: n = 44, abrasion: n = 37) besides treatment of the underlying pathology, 155 patients underwent defect debridement/chondroplasty. The patient-reported outcome was measured using the International Hip Outcome Tool 33 (iHOT33) score and the Visual Analogue Scale (VAS) for pain. RESULTS: iHOT33 and VAS both improved highly statistically significantly (p < 0.001) in the debridement group after 6, 12, 24, 36 and 60 months compared to the preoperative scores, whereas iHOT33 and VAS after microfracture or abrasion did not show statistically significant changes over time. Twenty-four and sixty months postsurgery the debridement group revealed significant higher scores in the iHOT33 compared to the bone marrow stimulation groups. CONCLUSION: Patients with chondral lesions of the hip ≤400 mm2 sustainably benefit from arthroscopic debridement under preservation of the subchondral bone plate in terms of functional outcome and pain in contrast to patients treated with bone marrow stimulation. These findings discourage the currently recommended use of microfracture in the hip joint. LEVEL OF EVIDENCE: Level III.

Sustained superiority in KOOS subscores after matrix-associated chondrocyte implantation using spheroids compared to microfracture.

PURPOSE: To evaluate the safety and efficacy of matrix-associated autologous chondrocyte implantation (ACI) using spheroids in comparison to arthroscopic microfracture for the treatment of symptomatic cartilage defects of the knee. METHODS: In a prospective multicenter-controlled trial, patients aged between 18 and 50 years, with single symptomatic focal cartilage defects between 1 and 4 cm2 (mean 2.6 ± 0.8, median 2.75, range 1.44-5.00) in the knee were randomized to treatment with ACI with spheroids (n = 52) or microfracture (n = 50). Primary clinical outcome was assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS). Analyses were performed in a defined hierarchical manner where outcomes of ACI were first compared to baseline values followed by a comparison to the microfracture group with repeated-measures ANCOVA with a non-inferiority approach. Subgroup analyses were performed to investigate the influence of age and defect size on the overall KOOS. Secondary clinical outcomes were the magnetic resonance observation of cartilage repair tissue (MOCART), modified Lysholm score and International Knee Documentation Committee (IKDC) examination form. Safety data focused on adverse events. Here the 5 years results are presented at which there were 33 observed cases in the ACI group and 30 in the microfracture group. RESULTS: The overall KOOS and its five subscores were significantly improved compared to baseline for both the ACI and microfracture group. Non-inferiority of ACI to microfracture was confirmed for the overall KOOS and the subscores, while for the subscores activities of daily living, quality of life and sports and recreation of the threshold for superiority was passed. In the ACI group, a notably more rapid initial improvement of the KOOS was found at three months for the older age group compared to the younger age group and the microfracture group. No other differences were found based on age or defect size. In addition, clinical improvement was found for the MOCART, modified Lysholm and IKDC examination form both the ACI and microfracture group. No safety concern related to either treatment was observed. CONCLUSION: This study confirms the safety and efficacy of matrix-associated ACI with spheroids at a mid to long-term follow-up. Non-inferiority of ACI to microfracture was confirmed for the overall KOOS and all subscores, while superiority was reached for the subscores activities of daily living, quality of life and sports and recreation in the ACI group. This underlines the importance of ACI for the young and active patients. LEVEL OF EVIDENCE: I.

Infiltration therapy in the context of cartilage surgery.

Guideline-based surgical cartilage therapy for focal cartilage damage offers highly effective possibilities to sustainably reduce patients' complaints and to prevent or at least delay the development of early osteoarthritis. In the knee joint, it has the potential to reduce almost a quarter of the arthroses requiring joint replacement caused by cartilage damage. Biologically effective injection therapies could further improve these results. Based on the currently available literature and preclinical studies, intra- and postoperative injectables may have a positive effect of platelet-rich plasma/fibrin (PRP/PRF) and hyaluronic acid (HA) on cartilage regeneration and, in the case of HA injections, also on the clinical outcome can be assumed. The role of a combination therapy with use of intra-articular corticosteroids is lacking in the absence of adequate study data and cannot be defined yet. With regard to adipose tissue-based cell therapy, the current scientific data do not yet justify any recommendation for its use. Further studies also regarding application intervals, timing and differences in different joints are required.

Current practice of concomitant surgeries in cartilage repair of the femorotibial compartment of the knee: baseline data of 4968 consecutive patients from the German cartilage registry (KnorpelRegister DGOU).

INTRODUCTION: The treatment of underlying comorbidities is a field of rising interest in cartilage repair surgery. The aim of this study was to analyze the current practice of concomitant surgeries in cartilage repair of the knee especially in the medial or lateral femorotibial compartment. Type, frequency and distribution of additional surgeries for correction of malalignment, knee instability and meniscus deficiency should be evaluated. METHODS: Baseline data of 4968 patients of the German Cartilage Registry (KnorpelRegister DGOU) were analyzed regarding the distribution of concomitant surgeries in addition to regenerative cartilage treatment. RESULTS: Beyond 4968 patients 2445 patients with cartilage defects in the femorotibial compartment of the knee could be identified. Of these patients 1230 (50.3%) received additional surgeries for correction of malalignment, instability and meniscus deficiency. Predominant procedures were leg axis corrections (31.3%), partial meniscectomy (20.9%) and ACL reconstruction (13.4%). The distribution of the concomitant surgeries varied between cartilage defects according to the different defect genesis. Patients with traumatic defects were younger (36y) and received predominantly ACL reconstructions (29.2%) (degenerative: 6.7%), whereas patients with degenerative defects were older (43y) and underwent predominantly leg axis corrections (38.0%; traumatic: 11.0%). CONCLUSIONS: This study shows the high frequency and distinct distribution of the concomitant surgeries in addition to regenerative cartilage treatment procedures. Understanding of the underlying cause of the cartilage defect and addressing the comorbidities as a whole joint therapy are of utmost importance for a successful regenerative cartilage treatment. These data provide a baseline for further follow up evaluations and long-term outcome analysis. LEVEL OF EVIDENCE: II.

Long-term cost-effectiveness of matrix-associated chondrocyte implantation in the German health care system: a discrete event simulation.

INTRODUCTION: Cartilage defects in the knee can be caused by injury, various types of arthritis, or degeneration. As a long-term consequence of cartilage defects, osteoarthritis can develop over time, often leading to the need for a total knee replacement (TKR). The treatment alternatives of chondral defects include, among others, microfracture, and matrix-associated autologous chondrocyte implantation (M-ACI). The purpose of this study was to determine cost-effectiveness of M-ACI in Germany with available mid- and long-term outcome data, with special focus on the avoidance of TKR. MATERIALS AND METHODS: We developed a discrete-event simulation (DES) that follows up individuals with cartilage defects of the knee over their lifetimes. The DES was conducted with a status-quo scenario in which M-ACI is available and a comparison scenario with no M-ACI available. The model included 10,000 patients with articular cartilage defects. We assumed Weibull distributions for short- and long-term effects for implant failures. Model outcomes were costs, number of TKRs, and quality-adjusted life years (QALYs). All analyses were performed from the perspective of the German statutory health insurance. RESULTS: The majority of patients was under 45 years old, with defect sizes between 2 and 7 cm2 (mean: 4.5 cm2); average modeled lifetime was 48 years. In the scenario without M-ACI, 26.4% of patients required a TKR over their lifetime. In the M-ACI scenario, this was the case in only 5.5% of cases. Thus, in the modeled cohort of 10,000 patients, 2700 TKRs, including revisions, could be avoided. Patients treated with M-ACI experienced improved quality of life (22.53 vs. 21.21 QALYs) at higher treatment-related costs (18,589 vs. 14,134 € /patient) compared to those treated without M-ACI, yielding an incremental cost-effectiveness ratio (ICER) of 3376 € /QALY. CONCLUSION: M-ACI is projected to be a highly cost-effective treatment for chondral defects of the knee in the German healthcare setting.

Primary surgery versus primary rehabilitation for treating anterior cruciate ligament injuries: a living systematic review and meta-analysis.

OBJECTIVE: Compare the effectiveness of primarily surgical versus primarily rehabilitative management for anterior cruciate ligament (ACL) rupture. DESIGN: Living systematic review and meta-analysis. DATA SOURCES: Six databases, six trial registries and prior systematic reviews. Forward and backward citation tracking was employed. ELIGIBILITY CRITERIA: Randomised controlled trials that compared primary reconstructive surgery and primary rehabilitative treatment with or without optional reconstructive surgery. DATA SYNTHESIS: Bayesian random effects meta-analysis with empirical priors for the OR and standardised mean difference and 95% credible intervals (CrI), Cochrane RoB2, and the Grading of Recommendations Assessment, Development and Evaluation approach to judge the certainty of evidence. RESULTS: Of 9514 records, 9 reports of three studies (320 participants in total) were included. No clinically important differences were observed at any follow-up for self-reported knee function (low to very low certainty of evidence). For radiological knee osteoarthritis, we found no effect at very low certainty of evidence in the long term (OR (95% CrI): 1.45 (0.30 to 5.17), two studies). Meniscal damage showed no effect at low certainty of evidence (OR: 0.85 (95% CI 0.45 to 1.62); one study) in the long term. No differences were observed between treatments for any other secondary outcome. Three ongoing randomised controlled trials were identified. CONCLUSIONS: There is low to very low certainty of evidence that primary rehabilitation with optional surgical reconstruction results in similar outcome measures as early surgical reconstruction for ACL rupture. The findings challenge a historical paradigm that anatomic instability should be addressed with primary surgical stabilisation to provide optimal outcomes. PROSPERO REGISTRATION NUMBER: CRD42021256537.

Preexisting and treated concomitant ankle instability does not compromise patient-reported outcomes of solitary osteochondral lesions of the talus treated with matrix-induced bone marrow stimulation in the first postoperative year: data from the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: The purpose of this study was to compare the subjective ankle function within the first year following matrix-induced bone marrow stimulation (M-BMS) of patients with a solitary osteochondral lesion of the talus (OCLT) with and without concomitant chronic ankle instability (CAI). METHODS: Data from the German Cartilage Registry (KnorpelRegister DGOU) for 78 patients with a solitary OCLT and a follow-up of at least 6 months were included. All patients received M-BMS for OCLT treatment. The cohort was subdivided into patients with OCLT without CAI treated with M-BMS alone (n = 40) and patients with OCLT and CAI treated with M-BMS and additional ankle stabilisation (n = 38). The Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS), and the Numeric Rating Scale for Pain (NRS) were used to assess patient-reported outcomes (median (minimum-maximum)). RESULTS: From preoperatively to 12 months postoperatively, patients with OCLT without CAI treated with M-BMS alone had a significant improvement of all subscales in the FAAM [activity of daily living 64.3 (10-100) to 88.1 (39-100); sports 34.4 (0-100) to 65.6 (13-94), functional activities of daily life 50 (0-90) to 80 (30-100), functional sports 30 (0-100) to 70 (5-100)] and FAOS [pain 61.1 (8-94) to 86.1 (50-100), symptoms 60.7 (18-96) to 76.8 (29-100), activities of daily living 72.1 (24-100) to 91.9 (68-100), sport/recreational activities 30.0 (0-70) to 62.5 (0-95), quality of life 31.3 (6-50) to 46.9 (19-100)]. Within the first year, patients with OCLT and CAI treated with M-BMS and ankle stabilisation also showed significant improvement in the FAAM [activity of daily living 68.8 (5-99) to 90.5 (45-100); sports 32.8 (0-87.5) to 64.1 (0-94), functional activities of daily life 62.5 (25-100) to 80 (60-90), functional sports 30 (0-100) to 67.5 (0.95)] and the FAOS [pain 66.7 (28-92) to 87.5 (47-100), symptoms 57.1 (29-96) to 78.6 (50-100), activities of daily living 80.1 (25-100) to 98.5 (59-100), sport/recreational activities 35.0 (0-100) to 70.0 (0-100), quality of life 25.0 (0-75) to 50.0 (19-94)]. The pain level decreased significantly in both groups. No significant difference was found between both groups regarding the subscales of FAAM, FAOS and the NRS 1 year postoperatively. CONCLUSION: Improvements in subjective ankle function, daily life activities and sports activities were observed within the first year following M-BMS. Our results suggest that preexisting and treated ankle instability did not compromise subjective outcome in patients treated with M-BMS in the first postoperative year. LEVEL OF EVIDENCE: Level IV.

Autologous chondrocyte implantation combined with anterior cruciate ligament reconstruction: similar short-term results in comparison with isolated cartilage repair in ligament intact joints.

PURPOSE: Both acute ruptures of the anterior cruciate ligament (ACL) as well as chronic ACL insufficiency show a high association with focal cartilage defects of the knee. However, the results after combined ACL reconstruction and cartilage repair are not well investigated. The aim of the present study was to investigate the short-term outcomes after autologous chondrocyte implantation (ACI) in combination with ACL reconstruction and to compare the results with patients who underwent isolated ACI in ligament intact knees. METHODS: All patients who were registered in the German Cartilage Registry with ACI for focal cartilage defects in the knee joint in combination with ACL reconstruction and who completed the 24 month follow-up were included in the study group. A matched-pair procedure according to gender, defect location, defect size, and age was used to create a control group of patients with isolated ACI in ACL intact joints. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and the numeric analog scale for pain (NAS) were used to assess the preoperative state as well as the clinical outcomes 12 and 24 months after surgery. RESULTS: A total of 34 patients were included in both the study group (age mean 33.3 ± SD 8.8 years) and the control group (33.6 ± 8.4 years) with a median defect size of 466 (25%-75% IQR 375-600) mm2 and 425 (IQR 375-600) mm2, respectively. In comparison with the preoperative state (median 67, IQR 52-75), the study group showed a significant increase of the total KOOS after 12 months (78, IQR 70-86; p = 0.014) and after 24 months (81, IQR 70-84; p = 0.001). The NAS for pain did not change significantly in the postoperative course. In comparison with the control group there was no significant difference for the total KOOS neither preoperative (control group median 67, IQR 52-73) nor at any postoperative time point (12 months: 82, IQR 67-93; 24 months: 81, IQR 71-91). CONCLUSION: The clinical short-term outcomes after ACI at the knee joint in combination with ACL reconstruction are good and similar to the results after isolated ACI in ligament intact knees. LEVEL OF EVIDENCE: III.

Factors correlating with patients' satisfaction after undergoing cartilage repair surgery-data from the German Cartilage Registry (KnorpelRegister DGOU).

Subjective patient satisfaction is the most relevant parameter for assessing the success of treatment after orthopaedic surgery. The aim of the present study was to correlate patient-reported outcome parameters (i.e., absolute KOOS, KOOS increase) and revision-free survival with patient's satisfaction. Furthermore, the study aimed on the identification of pre-operative factors that are associated with patient's satisfaction after the surgery.For the present study, 6305 consecutive patients from the German Cartilage Registry (KnorpelRegister DGOU) were analyzed. Patient characteristics and outcome were correlated with patients' satisfaction after a follow-up of three years by Spearman correlation. P values < 0.05 were considered statistically significant.Mean age was 37 ± 12.5 years, 59.7% patients were male, and 40.3% female. Most patients (46.7%) were treated with an autologous chondrocyte implantation (ACI). The strongest correlation of subjective satisfaction and the subscore quality of life (r = 0.682; p < 0.001) was found, whereas the post-operative increase in KOOS from the pre-operative value showed only a moderate correlation (r = 0.520; p < 0.001). There was also a significant correlation with the absolute KOOS value (r = 0.678; p < 0.001), the subscores pain (r = 0.652; p < 0.001), quality of life (r = 0.682; p < 0.001), and sports (r = 0.633; p < 0.001), whereas symptoms (r = 0.504, p < 0.001) and activities of daily life (r = 0.601; p < 0.001) showed a weaker correlation. Pain also correlated highly significant with the patient satisfaction 24 months after surgery (r = - 0.651, p < 0.001). The correlation between satisfaction after the 2nd and 3rd year (r = 0.727; p < 0.001) is stronger than correlation after six months and three years (r = 0.422, p < 0.001). All pre-operative parameters show a very weak correlation (r < 0.1).The use of standardized measuring instruments (KOOS and Pain) is a relevant outcome parameter in science and clinical practice, whereas absolute values represent satisfaction better than the individual increase. The subscores "pain," "quality of life," and "sports" represent satisfaction better than the subscores "symptoms" and "activity of daily life." Early satisfaction has only a moderate predictive value for satisfaction after 3 years, which is of great practical relevance in particular for the assessment of potential treatment failures. It is remarkable to note that a revision surgery is only very mildly associated with increased dissatisfaction. Pre-operative factors are not reliable prediction factors for post-operative patient satisfaction.

[The meaning of cartilage therapy in the treatment of FAIS : Is a specific cartilage therapy necessary or is deformity correction sufficient?] / Bedeutung der Knorpeltherapie in der Behandlung des FAIS : Ist eine spezifische Knorpeltherapie erforderlich oder reicht die Deformitätenkorrektur?

Femoroacetabular impingement syndrome (FAIS) surgery aims to restore the natural anatomical relationships between bones and the soft tissues comprising the hip joint. Most cartilage repair methods for the hip are based on basic science and strategies that were developed for the knee. Currently, there is a lack of information in the literature regarding systematic reviews on evidence-based options in treating cartilage injuries of the hip joint. The aim of this article is to assess treatment options and their related outcomes for chondral injuries in the hip based on the available evidence whilst highlighting new and innovative techniques.

[Intra-articular injury patterns as evidence of mechanical hip disorders]. / Intraartikuläre Schädigungsmuster als Hinweise auf mechanische Hüfterkrankungen.

FAIS is a well-defined clinical entity with morphological alterations, whether constitutional or acquired, that can lead to damage of the labrum and acetabular cartilage following distinct injury patterns with subsequent osteoarthritis. The combination pathology of cam and pincer deformity is the most common variant. The characteristic changes of the chondrolabral complex that are caused by the dysplasia differ from these FAIS changes. Furthermore, femoral torsion also has an impact on the clinical appearance of Cam- or Pincer-FAIS.

Parameters affecting baseline hip function in patients with cam-derived femoroacetabular impingement syndrome: data analysis from the German Cartilage Registry.

BACKGROUND: Using the database of the German Cartilage Registry (KnorpelRegister DGOU), this study aims to present patient- and joint-related baseline data in a large cohort of patients with cam-derived femoroacetabular impingement syndrome (FAI) and to detect symptom-determining factors. MATERIALS AND METHODS: Requiring cam morphology as the primary pathology, 362 patients were found to be eligible for inclusion in the study. The assessment of preoperative baseline data was performed using the patient-reported outcome measure-International Hip Outcome Tool (iHOT-33). Descriptive statistics were performed to present baseline data. Univariate and multiple regression with post hoc testing were used to identify patient- and joint-related factors that might affect the preoperative iHOT-33 and its subscores, respectively. RESULTS: The study collective's mean age was 36.71 ± 10.89 years, with 246 (68%) of them being male. The preoperative mean iHOT-33 total was 46.31 ± 20.33 with the subsection "sports and recreational activities" presenting the strongest decline (26.49 ± 20.68). The parameters "age," "sex," "body mass index" (BMI), and the confirmation of "previous surgery on the affected hip" were identified to statistically affect the preoperative iHOT-33. In fact, a significantly lower mean baseline score was found in patients aged > 40 years (p < 0.001), female sex (p < 0.001), BMI ≥ 25 kg/m2 (p = 0.002) and in patients with previous surgery on the affected hip (p = 0.022). In contrast, the parameters defect grade and size, labral tears, and symptom duration delivered no significant results. CONCLUSIONS: A distinct reduction in the baseline iHOT-33, with mean total scores being more than halved, was revealed. The parameters "age > 40 years," "female sex," "BMI ≥ 25," and confirmation of "previous surgery on the affected hip" were detected as significantly associated with decreased preoperative iHOT-33 scores. These results help to identify symptom-defining baseline characteristics of cam-derived FAI syndrome. TRIAL REGISTRATION: The German Cartilage Registry is conducted in accordance with the Declaration of Helsinki and registered at germanctr.de (DRKS00005617). Registered 3 January 2014-retrospectively registered. The registration of data was approved by the local ethics committees of every participating institution. Primary approval was given by the ethics committee at the University of Freiburg (No. 105/13). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005617.

Safety and efficacy of matrix-associated autologous chondrocyte implantation with spheroid technology is independent of spheroid dose after 4 years.

PURPOSE: The aim of this study was to investigate the effect of product dose in autologous chondrocyte implantation (ACI) for the treatment of full-thickness cartilage defects of the knee and to assess its influence on clinical and morphological mid-term outcome. METHODS: Seventy-five patients were included in this single-blind, randomised, prospective, controlled clinical trial. Patients were assigned randomly to three different dose groups [low (3-7 spheroids/cm2), medium (10-30 spheroids/cm2), or high (40-70 spheroids/cm2)] and assessed using standardised clinical and morphological scoring systems (KOOS, IKDC, MOCART) for 4 years following the intervention. RESULTS: The analysis population comprised 75 patients (22 women, 53 men) aged 34 ± 9 years. Defect sizes ranged from 2 to 10 cm2 following intraoperative debridement. The assessment of the primary variable 'overall KOOS' showed a statistically significant improvement, compared with baseline, for each dose group, i.e., at baseline the mean 'overall KOOS' scores were 60.4 ± 13.6, 59.6 ± 15.4, and 51.1 ± 15.4 for the low-, medium-, and high-dose groups, respectively, and 57.0 ± 15.2 for 'all patients'. After 48 months those values improved to 80.0 ± 14.7, 84.0 ± 14.9, and 66.9 ± 21.5 in the respective dose groups and 77.1 ± 18.6 for 'all patients'. Pairwise comparisons of these dose groups did not reveal any statistically significant differences. Likewise, assessment of the subjective IKDC score revealed no statistically significant differences between the three dose groups up to the 48-month visit. However, between 12 and 48 months there was a low, but steady, improvement in the low-dose group and a substantial amelioration in the medium-dose group. The mean MOCART total scores 3 months after treatment were 59.8 ± 10.9, 64.5 ± 10.3, and 64.7 ± 9.4 for the low-, medium-, and high-dose groups, and 62.9 ± 10.3 for 'all patients'; 48 months after treatment these were 73.9 ± 13.1, 78.0 ± 12.4, and 74.3 ± 14.0 for the respective dose groups and 75.5 ± 13.1 for 'all patients'. CONCLUSIONS: Results of this study confirm the efficacy and safety of the applied "advanced therapy medicinal product"; no dose dependence was found either for the incidence or for the severity of any adverse reactions. All doses applied in the present study led to significant clinical improvement over time and can therefore be regarded as effective doses. The influence of product doses in the range investigated seems to be low and can be neglected. Thus, the authorised dose range of 10-70 spheroids/cm2 confirmed by this clinical trial offers a broad therapeutic window for the surgeon applying the product, thereby reducing the risk of over- or underdosing. LEVEL OF EVIDENCE: I.

Decision making for concomitant high tibial osteotomy (HTO) in cartilage repair patients based on a nationwide cohort study of 4968 patients.

BACKGROUND: High tibial osteotomy (HTO) for varus deformities is a common concomitant treatment in cartilage surgery. Aim of the present study was to analyze factors influencing the decision towards accompanying HTO in patients with cartilage defects of the medial femoral condyle, such as the amount of varus deformity. METHODS: Data from 4986 patients treated for cartilage defects of the knee from the German Cartilage Registry (KnorpelRegister DGOU) were used for the current analysis. Seven hundred and thirty-six patients fulfilled the inclusion criteria. Their data were analyzed for factors influencing the decision towards performing a concomitant HTO using t test, univariate and multivariate binary logistic regression models. RESULTS: The break point at which the majority of patients receive a concomitant HTO is 3° of varus deformity. Several factors apart from the amount of varus deformity (5.61 ± 2.73° vs. 1.72 ± 2.38°, p < 0.00) differed significantly between the group of patients with HTO and those without. These included defect size (441.6 ± 225.3 mm2 vs. 386.5 ± 204.2 mm2, p = 0.001), symptom duration (29.53 ± 44.58 months vs. 21.85 ± 34.17 months, p = 0.021), defect grade (62.5% IVa/IVb vs. 57.3% IVa/IVb, p = 0.014), integrity of corresponding joint surface (10.8% grade III-IV vs. 0.2% grade III-IV, p < 0.001), meniscus status (15.5% > 1/3 resected vs. 4.4% > 1/3 resected, p < 0.001) and number of previous surgeries (1.01 ± 1.06 vs. 0.75 ± 1.00, p = 0.001). In the stepwise multivariate binary logistic regression test, only the amount of varus deformity, symptom duration and quality of the corresponding joint surface remained significant predictors associated with performing a concomitant HTO. CONCLUSION: Based upon data from a nationwide cohort, additional HTO in context with cartilage repair procedures of the medial femoral condyle is frequently performed even in mild varus deformities less than 5°. Other factors also seem to influence decision for HTO.

Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).

AIM: Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles. PATIENTS AND METHODS: 73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT). In dependence of defect location, patients were divided into two groups [patella defects (n = 45) and femoral condyle defects (n = 28)]. Clinical outcome was evaluated by the means of the KOOS score at baseline and 6 weeks, 3, 6, 12, 18, 24, 36, 48 and 60 months following ACI. RESULTS: "Responder rate" at 60 months (improvement from baseline of > 7 points in the KOOS score) in patients with patella defects was 86.2%. All scores showed a significant improvement from baseline. While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6 (SD 14.0) was observed in patella defects (p = 0.2483). CONCLUSION: ACI seems an appropriate surgical treatment for cartilage defects of the patella leading to a high success rate. In this study, the clinical outcome in patients with patellar defects was even better than the already excellent results in patients with defects of the femoral condyle even though the study included relatively large defect sizes for both groups (mean defect size 6.0 ± 1.7 and 5.4 ± 1.6 for femur and patella, respectively).

What parameters affect knee function in patients with untreated cartilage defects: baseline data from the German Cartilage Registry.

PURPOSE: To evaluate the factors influencing the baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) in patients with knee cartilage defects and planned cartilage repair surgery and to provide baseline KOOS data from a large patient population. MATERIAL AND METHODS: Between October 2013 and April 2017, a total of 2815 patients assigned for cartilage repair surgery were included into the German Cartilage Registry (KnorpelRegister DGOU) and their data were analyzed for the present study. Multivariate regression model and ANOVA were used to detect patient- and defect-specific factors with an influence on baseline KOOS. In addition, KOOS baseline data was calculated and compared according to these parameters. RESULTS: Sex, age, body mass index (BMI), and smoking status were revealed as patient-specific factors, and defect location and the number of previous knee and cartilage operations were revealed as defect-specific factors with a significant influence on baseline KOOS. Most subscores were affected in accordance with the total KOOS. Interestingly, defect ICRS grade, defect size, and symptom duration had no significant influence. The mean baseline KOOS was 56.7 (± 17.9). Men had significantly higher mean overall KOOS (60 ± 17.3 vs. 51.8 ± 17.6, p < 0.001) than women, and patients with a BMI over 30 and smokers scored significantly lower (58.07 ± 17.67 vs. 50.32 ± 17.29, p < 0.001; 57.64 ± 17.86 vs. 53.59 ± 18.06, p < 0.001). Patients with two or more previous knee operations as well as patients with more than one previous cartilage procedure also showed significantly lower overall KOOS (57.19 ± 17.89 vs. 54.56 ± 17.58, p < 0.001; 57.68 ± 18.01 vs. 52.72 ± 17.58, p < 0.001). CONCLUSION: Several factors influencing baseline KOOS data in patients with knee cartilage defects assigned for cartilage repair surgery could be detected. Their individual influence in the multivariate linear regression model was not very strong. Baseline data according to these criteria is presented in this paper.

Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces-ankle-foot orthosis versus knee unloader brace.

BACKGROUND: The use of an unloader brace is a non-surgical treatment option for patients with medial osteoarthritis (OA). However, many patients do not adhere to brace treatment, because of skin irritation due to the pads at the level of the joint space and bad fit. A new concept to unload the medial compartment of the knee is a foot ankle brace with a lever arm pressing the thigh in valgus. The aim of this prospective randomized trial was to examine the outcomes of patients with medial OA after treatment with a conventional knee unloader brace (Unloader One®) and the new foot ankle orthosis (Agilium FreeStep®). METHODS: For this multicenter trial, 160 patients (> 35 years) with medial OA were randomly allocated to treatment with a conventional knee unloader brace (Unloader One®) or treatment with the new knee OA ankle brace (Agilium FreeStep®). The primary outcome measure was pain (numerical analog scale) at baseline (T0), 8 weeks (T1), and 6 months (T2). Secondary outcome measures were knee function (Knee Injury and Osteoarthritis Outcome Score, KOOS), side effects, additional interventions, and compliance. RESULTS: In both groups, walking pain improved between T0 and T1 and also between T0 and T2 without a significant group difference. For pain at sports, both groups showed a significant improvement between T0 and T2 without a significant group difference. The KOOS subscales symptoms, pain, activity, sport, and quality of life increased significantly in both treatment groups without any significant group differences at T 0, T1, and T2. There was also no significant group difference in additional interventions and weekly or daily brace use. In the Agilium FreeStep® group (23.5%), significantly less patients reported bruises in contrast to the Unloader One® group (66.7%). DISCUSSION: The results of this clinical trial show that the foot ankle brace is as effective as a conventional knee unloader brace for the treatment of medial knee OA with regard to clinical outcome. The rate of side effects such as bruises was significantly lower in the Agilium FreeStep® group. TRIAL REGISTRATION: DRKS00009215, 13.8.2015.

Correction to: Parameters influencing complaints and joint function in patients with osteochondral lesions of the ankle-an investigation based on data from the German Cartilage Registry (KnorpelRegister DGOU).

The original version of this article contained an error.