Postoperative Management of Osteochondral Lesions of the Ankle: A Survey Among German-Speaking Foot and Ankle Surgeons.

OBJECTIVE: To assess the current treatment of osteochondral lesions of the ankle (OCLA) by German-speaking foot and ankle surgeons, focusing on the management of postoperative care and rehabilitation. DESIGN: A questionnaire was created by a panel of 4 experienced foot and ankle surgeons on behalf of the "Clinical Tissue Regeneration" (CTR) working group of the German Society of Orthopaedics and Trauma Surgery (DGOU), and distributed electronically to members of the CTR, participants of the German Cartilage Registry (Knorpelregister DGOU©), and members of 6 German-speaking orthopedics or sports medicine societies. Results were classified depending on the consensus within the answers (agreement ≥75% "strong tendency," 50%-74% "tendency," 25%-49% "weak tendency," <25% "no tendency"). RESULTS: A total of 60 participants returned the questionnaire. The main results are as follows: regarding the frequency of surgical procedures for OCLA, refixation of the fragment, retrograde drilling, and bone marrow stimulation with or without using a matrix were performed by at least 75% of the surgeons and was considered a strong tendency. There was a strong tendency to stabilize the ankle (76.7%) and perform corrective osteotomies (51.7%). In total, 75.5% and 75% of the surgeons performed bone marrow stimulation with and without using a matrix, respectively. Corrective osteotomy and ankle stabilization were performed in 64.5% and 65.2% cases, respectively. Most participants included published recommendations on postoperative rehabilitation and the return to sports activities in their postoperative management. The main surgical procedures were considered the most critical factor in influencing the postoperative management by 81% of the participants (strong tendency). Adjunct surgical procedures such as corrective osteotomy and stabilization of the ankle were considered important by 67.8% of the respondents (tendency). CONCLUSIONS: The management of OCLA varies among German-speaking foot and ankle surgeons. Therefore, guidelines remain essential to standardize the management of OCLA, to achieve improved and stable results. This survey will assist clinicians and patients with rehabilitation to return to sports after treating the ankle's cartilage injury.

Revision of inlay resurfacing prosthesis with patellar realignment surgery and a new inlay prosthesis for persistent patellofemoral pain und patella subluxation.

We present the case of a 35-year-old patient who underwent inlay patellofemoral arthroplasty (I-PFA) followed by secondary patellar realignment surgery and inlay-to-inlay revision. Revision was performed because of ongoing pain, crepitation, and lateral subluxation of the patella. The original patella component (30-mm button) was replaced with a 35-mm dome, while the Hemi-Cap Wave® (7 × 5 mm) I-PFA was replaced with the Hemi-Cap Kahuna® (10 × 5 mm). At the 1-year follow-up, the clinical symptoms were resolved. Radiography revealed an aligned patellofemoral compartment with no signs of loosening. Inlay-to-inlay PFA revision appears to be a reasonable alternative to total knee arthroplasty and conversion to onlay-PFA (O-PFA) for symptomatic patients with primary I-PFA failure. Thorough patellofemoral evaluation and appropriate patient and implant selection are key for successful I-PFA, while additional procedures for patellar realignment may also be required for satisfactory long-term outcomes.

High degree of consensus amongst an expert panel regarding focal resurfacing of chondral and osteochondral lesions of the femur with mini-implants.

INTRODUCTION: The rationale for the use of mini-implants for partial resurfacing in the treatment of femoral chondral and osteochondral lesions is still under debate. The evidence supporting best practise guidelines is based on studies with low-level evidence. A consensus group of experts was convened to collaboratively advance towards consensus opinions regarding the best available evidence. The purpose of this article is to report the resulting consensus statements. METHODS: Twenty-five experts participated in a process based on the Delphi method of achieving consensus. Questions and statements were drafted via an online survey of two rounds, for initial agreement and comments on the proposed statements. An in-person meeting between the panellists was organised during the 2022 ESSKA congress to further discuss and debate each of the statements. A final agreement was made via a final online survey a few days later. The strength of consensus was characterised as: consensus, 51-74% agreement; strong consensus, 75-99% agreement; unanimous, 100% agreement. RESULTS: Statements were developed in the fields of patient assessment and indications, surgical considerations and postoperative care. Between the 25 statements that were discussed by this working group, 18 achieved unanimous, whilst 7 strong consensus. CONCLUSION: The consensus statements, derived from experts in the field, represent guidelines to assist clinicians in decision-making for the appropriate use of mini-implants for partial resurfacing in the treatment of femoral chondral and osteochondral lesions. LEVEL OF EVIDENCE: Level V.

Etiology, Classification, Diagnostics, and Conservative Management of Osteochondral Lesions of the Talus. 2023 Recommendations of the Working Group "Clinical Tissue Regeneration" of the German Society of Orthopedics and Traumatology.

METHODS: Peer-reviewed literature was analyzed regarding different topics relevant to osteochondral lesions of the talus (OLTs) treatment. This process concluded with a statement for each topic reflecting the best scientific evidence available for a particular diagnostic or therapeutic concept, including the grade of recommendation. Besides the scientific evidence, all group members rated the statements to identify possible gaps between literature and current clinical practice. CONCLUSION: In patients with minimal symptoms, OLT progression to ankle osteoarthritis is unlikely. Risk factors for progression are the depth of the lesion on MRI, subchondral cyst formation, and the extent of bone marrow edema. Conservative management is the adaptation of activities to the performance of the ankle joint. A follow-up imaging after 12 months helps not to miss any progression. It is impossible to estimate the probability of success of conservative management from initial symptoms and imaging. Cast immobilization is an option in OLTs in children, with a success rate of approximately 50%, although complete healing, estimated from imaging, is rare. In adults, improvement by conservative management ranges between 45% and 59%. Rest and restrictions for sports activities seem to be more successful than immobilization. Intra-articular injections of hyaluronic acid and platelet-rich plasma can improve pain and functional scores for more than 6 months. If 3 months of conservative management does not improve symptoms, surgery can be recommended.

Femoral condyle resurfacing using an inlay metal implant: low revision rate of 266 patients in a 5-10 years follow-up.

PURPOSE: To assess the clinical outcome and survival of an inlay resurfacing prosthesis for focal femoral condyle chondral and osteochondral defects. METHODS: Two hundred sixty-six patients (mean age, 38.25 years; range 25-56 years) with symptomatic femoral condyle chondral and osteochondral defects were reviewed. The mean follow-up period was 7.3 years (range 5-10 years). The medial femoral condyle was involved in 229 and the lateral condyle in 37 patients. Previous cartilage surgery was done in 235 patients. All patients were treated with focal femoral condyle resurfacing with the HemiCAP® device. The preoperative and the last follow-up values of the Knee Injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), 36-item Short Form Survey (SF-36) and Visual Analogue Scale (VAS) were examined. Complications, reoperation rate and survival were analyzed. RESULTS: At the last follow-up, all clinical score values showed significant improvement as compared with the corresponding preoperative values (p < 0.001). Age presented a negative correlation with KOOS (p = 0.03) and SF-36 improvement (p = 0.014). Kellgren-Lawrence grade influenced OKS (p = 0.036). BMI, gender, side, medial or lateral condyle and size did not affect the outcome. Patients who had previous biological cartilage procedures demonstrated better clinical improvement in comparison with those that did not have prior surgery (p < 0.05). Survival was 96.2% at 10 years, using as endpoint implant revision or/and progression of osteoarthritis. The cumulative hazard for any-reason reoperation was 12.0%. CONCLUSIONS: Femoral condyle resurfacing using the HemiCAP® device is an effective treatment option to address focal chondral and osteochondral defects. It can be successfully used either as a primary procedure or after prior biological cartilage reconstruction. Subjective clinical outcomes are expected to be good to excellent in mid- to long term, while reoperation and revision rates are low. Progression of osteoarthritis is the most common mode of failure; thus, patient selection is very important. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Empfehlungen der AG Klinische Geweberegeneration zur Behandlung von Knorpelschäden am Kniegelenk. / Empfehlungen der AG Klinische Geweberegeneration zur Behandlung von Knorpelschäden am Kniegelenk.

The Working Group of the German Orthopedic and Trauma Society (DGOU) on Tissue Regeneration has published recommendations on the indication of different surgical approaches for treatment of full-thickness cartilage defects in the knee joint in 2004, 2013 and 2016. Based upon new scientific knowledge and new developments, this recommendation is an update based upon the best clinical evidence available. In addition to prospective randomised controlled clinical trials, this also includes studies with a lower level of evidence. In the absence of evidence, the decision is based on a consensus process within the members of the working group.The principle of making decision dependent on defect size has not been changed in the new recommendation either. The indication for arthroscopic microfracturing has been reduced up to a defect size of 2 cm2 maximum, while autologous chondrocyte implantation is the method of choice for larger cartilage defects. Additionally, matrix-augmented bone marrow stimulation (mBMS) has been included in the recommendation for defects ranging from 1 to 4.5 cm2. For the treatment of smaller osteochondral defects, in addition to osteochondral transplantation (OCT), mBMS is also recommended. For larger defects, matrix-augmented autologous chondrocyte implantation (mACI/mACT) in combination with augmentation of the subchondral bone is recommended.

Discharging the medial knee compartment: comparison of pressure distribution and kinematic shifting after implantation of an extra-capsular absorber system (ATLAS) and open-wedge high tibial osteotomy-a biomechanical in vitro analysis.

PURPOSE: Young and active patients suffering early degenerative changes of the medial compartment with an underlying straight-leg axis do face a therapeutical gap as unloading of the medial compartment cannot be achieved by high tibial osteotomy. Extracapsular absorbing implants were developed to close this existing therapeutical gap. Purpose of the present cadaveric biomechanical study was to compare the unloading effect of the knee joint after implantation of an extra-articular absorber system (ATLAS) in comparison to open-wedge high tibial osteotomy (OW-HTO) under physiological conditions. The hypothesis of the study was that implantation of an extra-capsular absorber results in an unloading effect comparable to the one achievable with OW-HTO. METHODS: Eight fresh-frozen cadaveric knees were tested under isokinetic flexion-extension motions and physiological loading using a biomechanical knee simulator. Tibiofemoral area contact and peak contact pressures were measured using pressure-sensitive film in the untreated medial compartment. The tibiofemoral superior-inferior, latero-medial translation and varus/valgus rotation were measured with a 3D tracking system Polaris. Pressures and kinematics changes were measured after native testing, ATLAS System implantation and OW-HTO (5° and 10° correction angles) performed with an angular stable internal fixator (TomoFix). RESULTS: The absorber device decreased the pressure in the medial compartment near full extension moments. Implantation of the ATLAS absorbing system according to the manufacturers' instruction did not result in a significant unloading effect. Deviating from the surgery manual provided by the manufacturer the implantation of a larger spring size while applying varus stress before releasing the absorber resulted in a significant pressure diminution. Contact pressure decreased significantly Δ0.20 ± 0.04 MPa p = 0.044. Performing the OW-HTO in 5° correction angle resulted in significant decreased contact pressure (Δ0.25 ± 0.10 MPa, p = 0.0036) and peak contact pressure (Δ0.39 ± 0.38 MPa, p = 0.029) compared with the native test cycle. With a 10° correction angle, OW-HTO significantly decreased area contact pressure by Δ0.32 ± 0.09 MPa, p = 0.006 and peak contact pressure by Δ0.48 ± 0.12 MPa, p = 0.0654 compared to OW-HTO 5°. Surgical treatment did not result in kinematic changes regarding the superior-inferior translation of the medial joint section. A significant difference was observed for the translation towards the lateral compartment for the ATLAS system Δ1.31 ± 0.54 MPa p = 0.022 and the osteotomy Δ3.51 ± 0.92 MPa p = 0.001. Furthermore, significant shifting varus to valgus rotation of the treated knee joint was verified for HTO 5° about Δ2.97-3.69° and for HTO 10° Δ4.11-5.23° (pHTO 5 = 0.0012; pHTO 10 = 0.0007) over the entire extension cycle. CONCLUSION: OW-HTO results in a significant unloading of the medial compartment. Implantation of an extra-capsular absorbing device did not result in a significant unloading until the implantation technique was applied against the manufacturer's recommendation. While the clinical difficulty for young and active patients with straight-leg axis and early degenerative changes of the medial compartment persists further biomechanical research to develop sufficient unloading devices is required.

Arthroscopic defect size measurement in osteochondral lesions of the talus underestimates the exact defect size and size measurement with arthro-MRI (MR-A) and high-resolution flat-panel CT-arthro imaging (FPCT-A).

PURPOSE: The size of osteochondral lesions of the talus (OLTs) is highly relevant for their treatment. In addition to intraoperative measurement of defect size, preoperative planning by means of magnetic resonance imaging (MRI) or computed tomography (CT) is crucial. METHODS: Four defects of different sizes and depths were created on the talar joint surface in 14 cadaver feet. All defects were evaluated, both arthroscopically and via arthrotomy with a probe. Arthro-MRI (MR-A) and high-resolution flat-panel CT arthro scans (FPCT-A) were acquired. Length, width, and depth were measured for every defect and the defect volume was calculated. To determine the exact defect size, each talar defect was filled with plastic pellets to form a cast and the casts were scanned using FPCT to create a 3D multiplanar reconstruction data set. Finally, the surgically measured values were compared with the radiological values and the exact defect size. RESULTS: Overall, the surgically measured values (both arthroscopic and open) underestimated the exact defect size (p < 0.05). Arthroscopically determined defect length and width showed the largest deviation (p < 0.05) and underestimated the size in comparison with MR-A and FPCT-A. The FPCT-A measurements demonstrated higher correlation with both the arthroscopic and open surgical measurements than did the MR-A measurements (p < 0.05). CONCLUSION: The exact defect size is underestimated on intraoperative measurement, in both arthroscopic and open approaches. Arthroscopic defect size measurement underestimates defect size in comparison with MR-A and FPCT-A. FPCT-A was shown to be a reliable imaging technique that allows free image reconstruction in every plane and could be considered as the new reference standard for preoperative evaluation of defect size in OLT.

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.

The novel dynamic MPFL-reconstruction technique: cheaper and better?

PURPOSE: Reconstruction of the medial patellofemoral ligament (MPFL) is an established procedure to restore patellar stability. Aim of this study is to evaluate the results of a dynamic MPFL reconstruction technique in a large university hospital setting. METHODS: Two hundred and thirteen consecutive patients with 221 knees were surgically treated for recurrent lateral patellar dislocation. All patients obtained dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was performed by oblique transpatellar tunnel transfer. Follow-up data including Kujala and BANFF score, pain level as well as recurrent patella instability were collected at a minimum follow-up of 2 years. RESULTS: Follow-up could be obtained from 158 patients (71%). The mean follow-up time was 5.4 years. Mean pain level was 1.9 ± 2.0 on the VAS. Mean Kujala score was 78.4 ± 15.5. Mean BANFF score was 62.4 ± 22.3. MPFL-reconstructions that were performed by surgeons with a routine of more than ten procedures had a significantly shorter surgical time 52.3 ± 17.6 min. Male patients yielded higher satisfaction rates and better clinical scores compared to females. Complications occurred in 27.2% of procedures, 20.9% requiring revision surgery of which were 9.5% related to recurrent patellar instability. 78% of all patients indicated they would undergo the procedure again. CONCLUSION: Dynamic MPFL reconstruction presents a reproducible procedure with increased complication rates, inferior to the results of static reconstruction described in the literature. Despite, it appears to be an efficient procedure to restore patellar stability in a large university hospital setting, without the necessity for intraoperative fluoroscopy. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov with the registration number NCT04438109 on June 18th 2020.

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.

The lack of retropatellar resurfacing at index surgery is significantly associated with failure in patients following patellofemoral inlay arthroplasty: a multi-center study of more than 260 patients.

PURPOSE: To evaluate the clinical outcomes of patients with a minimum 2-year follow-up following contemporary patellofemoral inlay arthroplasty (PFIA) and to identify potential risk factors for failure in a multi-center study. METHODS: All patients who underwent implantation of PFIA between 09/2009 and 11/2016 at 11 specialized orthopedic referral centers were enrolled in the study and were evaluated retrospectively at a minimum 2-year follow-up. Clinical outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Tegner Scale, the visual analogue scale (VAS) for pain, and subjective patient satisfaction. Pre- and perioperative risk factors were compared among failures and non-failures to determine potential risk factors. RESULTS: A total of 263 patients (85% follow-up rate) could be enrolled. The mean age at the time of index surgery was 49 ± 12 years with a mean postoperative follow-up of 45 ± 18 months. The overall failure rate was 11% (28 patients), of which 18% (5 patients) were patients with patella resurfacing at index surgery and 82% (23 patients) were patients without initial patella resurfacing. At final follow-up, 93% of the patients who did not fail were satisfied with the procedure with a mean transformed WOMAC Score of 84.5 ± 14.5 points, a mean KOOS Score of 73.3 ± 17.1 points, a mean Tegner Score of 3.4 ± 1.4 points and a mean VAS pain of 2.4 ± 2.0 points. An increased BMI was significantly correlated with a worse postoperative outcome. Concomitant procedures addressing patellofemoral instability or malalignment, the lack of patellofemoral resurfacing at the index surgery and a high BMI were significantly correlated with failure in our patient cohort. CONCLUSION: Patellofemoral inlay arthroplasty shows high patient satisfaction with good functional outcomes at short-term follow-up and thus can be considered a viable treatment option in young patients suffering from isolated patellofemoral arthritis. Patellar resurfacing at index surgery is recommended to decrease the risk of failure. LEVEL OF EVIDENCE: Retrospective case series, Level IV.

Operative Treatment Options for Patellofemoral Arthritis: An Expert Recommendation of the AGA Patellofemoral Committee.

BACKGROUND: The operative therapy of patellofemoral arthritis requires an individual approach depending on the underlying injury. However, the literature lacks recommendations for its course of action. PURPOSE: To generate an expert recommendation of therapy for different patellofemoral abnormalities in patients suffering from isolated patellofemoral arthritis. STUDY DESIGN: Consensus statement. METHODS: To generate recommendations, the AGA Patellofemoral Committee performed a consensus process using the Delphi method based on the available literature on isolated patellofemoral arthritis. RESULTS: In most statements and recommendations, a high percentage of consensus could be found. However, also in the expert group of the AGA Patellofemoral Committee, some controversies on the treatment of patellofemoral arthritis exist. CONCLUSION: The operative therapy of isolated patellofemoral arthritis is a challenging topic that leads to controversial discussions, even in an expert group. With this consensus statement of the AGA Patellofemoral Committee, recommendations on different operative treatment options were able to be generated, which should be considered in clinical practice.

Influence of the Medial Malleolus Osteotomy on the Clinical Outcome of M-BMS + I/III Collagen Scaffold in Medial Talar Osteochondral Lesion (German Cartilage Register/Knorpelregister DGOU).

OBJECTIVE: Osteochondral lesions of the talus are common injuries, with one of the leading treatment options being the M-BMS (matrix-augmented bone marrow stimulation) + I/III collagen scaffold. Osteotomy of the medial malleolus is not unusual but presents the risk of malunion or irritation by hardware. The aim of the study was to analyze data from the German Cartilage Society (Knorpelregister DGOU) to evaluate the influence of medial malleolar osteotomy on clinical results of M-BMS + I/III collagen scaffold. DESIGN: The ankle module of the Cartilage Register includes a total of 718 patients, while 45 patients met the inclusion criteria. Patients were treated with an M-BMS + I/III collagen scaffold of the medial talus, 30 without and 15 with an osteotomy of the medial malleolus. The follow-up evaluations included FAAM (Foot and Ankle Ability Measure), FAOS (Foot and Ankle Outcome Score), and VAS (visual analogue scale). RESULTS: Forty-five patients (22 male, 23 female) aged between 18 and 69 years (mean: 34 years) were included in this study. Between preoperative and 12 months postoperative, we noted a significant improvement in FAAM-ADL (Activity of Daily Living) (P = 0.004) as well as FAOS-Pain (P = 0.001), FAOS-Stiffness (P = 0.047), FAOS-ADL (P = 0.002), FAOS-Sport (P = 0.001), and FAOS Quality of Life (P = 0.009). There was no significant difference between patients who underwent an osteotomy or not. CONCLUSION: The results show a significant improvement in patients' outcome scores following a M-BMS + I/III collagen scaffold. No statistical difference was noted among those undergoing medial malleolar osteotomy.

Concomitant ankle instability has a negative impact on the quality of life in patients with osteochondral lesions of the talus: data from the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: The purpose of this study was to compare patients with osteochondral lesions of the talus (OCLT) with and without concomitant chronic ankle instability (CAI). METHODS: Data from the German Cartilage Registry (KnorpelRegister DGOU) for 63 patients with a solitary OCLT were used. All patients received autologous matrix-induced chondrogenesis (AMIC) for OCLT treatment. Patients in group A received an additional ankle stabilisation, while patients in group B received AMIC alone. Both groups were compared according to demographic, lesion-related, and therapy-related factors as well as baseline clinical outcome scores at the time of surgery. The Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS), and the Numeric Rating Scale for Pain (NRS) were used. RESULTS: Patients in group A were older compared to group B [median 34 years (range 20-65 years) vs. 28.5 years (range 18-72 years)]; the rate of trauma-associated OCLTs was higher (89.7% vs. 38.3%); more patients in group A had a previous non-surgical treatment (74.1% vs. 41.4%); and their OCLT lesion size was smaller [median 100 mm2 (range 15-600 mm2) vs. 150 mm2 (range 25-448 mm2)]. Most OCLTs were located medially in the coronary plane and centrally in the sagittal plane in both groups. Patients in group A had worse scores on the FAOS quality-of-life subscale compared to patients in group B. CONCLUSION: Patients with OCLT with concomitant CAI differ from those without concomitant CAI according to demographic and lesion-related factors. The additional presence of CAI worsens the quality of life of patients with OCLT. Patients with OCLT should be examined for concomitant CAI, so that if CAI is present, it can be integrated into the treatment concept. LEVEL OF EVIDENCE: IV.

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.

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).

A Prospective, Randomized, Open-Label, Multicenter, Phase III Noninferiority Trial to Compare the Clinical Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroid Technology Versus Arthroscopic Microfracture for Cartilage Defects of the Knee.

BACKGROUND: Autologous chondrocyte implantation (ACI) and microfracture are established treatments for large, full-thickness cartilage defects, but there is still a need to expand the clinical and health economic knowledge of these procedures. PURPOSE: To confirm the noninferiority of ACI compared with microfracture. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: Patients were randomized to be treated with matrix-associated ACI using spheroid technology (n = 52) or microfracture (n = 50). Both procedures followed standard methods. Patients were assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS), MOCART (magnetic resonance observation of cartilage repair tissue) scoring system, Bern score, modified Lysholm score, International Cartilage Repair Society (ICRS) rating (histological and immunochemical scoring after rebiopsy 24 months after implantation), and International Knee Documentation Committee (IKDC) examination form. The main assessments were conducted 24 months after study treatment. RESULTS: In the primary intention-to-treat analysis, the overall KOOS score for both ACI and microfracture yielded a statistically significant improvement relative to baseline. According to the between-group analysis, ACI passed the test of noninferiority compared with microfracture; thus, the primary goal of the study was achieved. The KOOS subscores yielded the same qualitative results as the overall KOOS score (ie, for each of these, noninferiority was demonstrated), and in 1 case (Activities of Daily Living subscore), the threshold for superiority was passed. The subgroup analyses did not yield any clear evidence of an association between treatment effect and any of the categories investigated (age, diagnosis, defect localization, sex). A histological analysis of biopsies from 16 patients (ACI: n = 9; microfracture: n = 7) suggested a better quality of repair in the patients treated with ACI. CONCLUSION: The efficacy of both ACI and microfracture was demonstrated with respect to both functional outcomes and morphological repair. The primary analysis confirmed the statistical hypothesis of the noninferiority of ACI, even for relatively small cartilage defects (1-4 cm2) treated in this study, the indication for which microfracture is generally accepted as the standard of care. ACI showed significant superiority in the KOOS subscores of Activities of Daily Living at 24 months and Knee-related Quality of Life at 12 months. REGISTRATION: NCT01222559 (ClinicalTrials.gov identifier).

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.

Arthroscopic microfracture vs. arthroscopic autologous matrix-induced chondrogenesis for the treatment of articular cartilage defects of the talus.

PURPOSE: Microfracture is an established method to treat osteochondral defects of the talus. The value of the addition of an acellular matrix is still under debate. This study compared the results of arthroscopic microfracture vs. arthroscopic autologous matrix-induced chondrogenesis using a collagen I/III matrix (AMIC) in the management of articular cartilage defects of the talus. METHODS: Patients with a minimum follow-up of 5 years after arthroscopic management for an articular cartilage defect of the talus with either microfracture alone or an additional acellular matrix were matched according to age, sex and BMI. The Hannover Scoring System for the ankle (HSS) and a Visual analog scale (VAS) for pain, function and satisfaction were used to evaluate the clinical outcome. Postoperative MRI was used to assess cartilage repair tissue based on the degree of defect repair and filling of the defect, integration to border zone, surface of the repair tissue, structure of the repair tissue, and subchondral bone alterations. RESULTS: Thirty-two patients (16 microfracture, 16 AMIC) were included. No significant between-group differences were observed in demographic data and preoperative score values. Both groups showed statistically significant improvement when comparing the pre- and postoperative score values. No statistically significant differences were identified between the median values of the groups with the HSS (microfracture: 82 (range 71-96) points; AMIC 88 (range 40-98) points). Accordingly, no significant differences were observed for the VAS pain (microfracture: 0.95 (range 0-3.8); AMIC: 1.0 (range 0-8.5)), VAS function (microfracture: 8.4 (range 3.5-10); AMIC: 9.0 (range 1.5-10)) and VAS satisfaction (microfracture: 8.9 (range 2.8-10); AMIC: 9.45 (range 1.5-10)). MRI showed regeneration of tissue in the treated area without differences between the two groups. CONCLUSION: Good clinical results were observed for arthroscopic microfracture with or without an additional acellular collagen I/III matrix in the treatment for articular cartilage defects of the talus. It appears that for defects as treated in this study, it is not worthwhile adding the collagen I/III matrix to the microfractures. LEVEL OF EVIDENCE: III.