Dataset Information

Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial.

ABSTRACT:

Objective

To evaluate the clinical outcome of a hydrogel-based autologous chondrocyte implantation (ACI) for large articular cartilage defects in the knee joint.

Design

Prospective, multicenter, single-arm, phase III clinical trial. ACI was performed in 100 patients with focal full-thickness cartilage defects ranging from 4 to 12 cm² in size. The primary outcome measure was the responder rate at 2 years using the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Results

Two years after ACI treatment, 93% of patients were KOOS responders having improved by ≥10 points compared with their pre-operative level. The primary endpoint of the study was met and demonstrated that the KOOS response rate is markedly greater than 40% with a lower 95% CI (confidence interval) of 86.1, more than twice the pre-specified no-effect level. KOOS improvement (least squares mean) was 42.0 ± 1.8 points (95% CI between 38.4 and 45.7). Mean changes from baseline were significant in the overall KOOS and in all 5 KOOS subscores from Month 3 (first measurement) to Month 24 (inclusive) (P < 0.0001). The mean MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) score after 24 months reached 80.0 points (95% CI: 70.0-90.0 points) and 92.1 points in lesions ≤ 5 cm².

Conclusions

Overall, hydrogel-based ACI proved to be a valuable treatment option for patients with large cartilage defects in the knee as demonstrated by early, statistically significant, and clinically meaningful improvement up to 2 years follow-up. Parallel to the clinical improvements, MRI analyses suggested increasing maturation, re-organization, and integration of the repair tissue.

Trial registration

NCT03319797; EudraCT No.: 2016-002817-22.

SUBMITTER: Niemeyer P

PROVIDER: S-EPMC9137299 | biostudies-literature | 2022 Jan-Mar

REPOSITORIES: biostudies-literature

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Publications

Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial.

Niemeyer P P Hanus M M Belickas J J László T T Gudas R R Fiodorovas M M Cebatorius A A Pastucha M M Hoza P P Magos K K Izadpanah K K Paša L L Vásárhelyi G G Sisák K K Mohyla M M Farkas C C Kessler O O Kybal S S Spiro R R Köhler A A Kirner A A Trattnig S S Gaissmaier C C

Cartilage 20220101 1

<h4>Objective</h4>To evaluate the clinical outcome of a hydrogel-based autologous chondrocyte implantation (ACI) for large articular cartilage defects in the knee joint.<h4>Design</h4>Prospective, multicenter, single-arm, phase III clinical trial. ACI was performed in 100 patients with focal full-thickness cartilage defects ranging from 4 to 12 cm<sup>2</sup> in size. The primary outcome measure was the responder rate at 2 years using the Knee Injury and Osteoarthritis Outcome Score (KOOS).<h4>R ...[more]

PMID: 35354310

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Project description:IntroductionAutologous chondrocyte implantation (ACI) is a crucial method for the treatment of defects in articular cartilage. However, the extant methods for the preparation of autologous chondrocyte patch are relatively complicated and money-consuming. Therefore, an efficient, reliable, easy-to-follow, and cost-effective technique is needed to overcome constraints. This case report aims to introduce an autologous chondrocyte patch fabrication technique to repair knee joint cartilage defects and report our typical cases with a 2-year follow-up.Case presentationWe described four cases in which patients complained of knee joint pain. According to radiological examination, the patients were diagnosed as knee joint cartilage defect. Arthroscopy and autologous chondrocyte patch implantation were performed as well as a 2-year follow up of patients. The autologous chondrocyte patch for knee joint cartilage repair was fabricated using a "sandwich" technique. The preoperative and postoperative knee function was evaluated by four subjective evaluation systems. MRI was performed for all patients to achieve more intuitionistic observation of the postoperative radiological changes of defect sites. The quality of repaired tissue was evaluated by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART). Postoperative follow-up showed improvement in clinical and MOCART scores for all patients. However, one patient complained of knee joint pain after walking for a long time or recreational activities from 12- to 18-month postoperatively. The location of pain for this patient was not in accordance with the location of cartilage defect.ConclusionThe patients undergoing autologous chondrocyte patch implantation demonstrated clinical improvement and good quality of repaired tissue postoperatively. The procedure is an efficient and cost-effective treatment for knee joint cartilage defect in this report. In addition, patients with osteoarthritis carry the risk of a poor outcome after the procedure, and whether to have a procedure should be considered carefully.

Project description:BackgroundFocal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run.Methods/designWe will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires, clinical parameters, clinical hop tests and radiographs and Magnetic Resonance Imaging (MRI) will be used as secondary endpoints.DiscussionThis is the first study with a high level of evidence to compare ACI with simple debridement and physiotherapy for the treatment of isolated symptomatic full thickness lesions of the knee.Trial registrationClinicalTrial NCT02636881 (21 December 2015).

Project description:BackgroundAutologous 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.PurposeTo confirm the noninferiority of ACI compared with microfracture.Study designRandomized controlled trial; Level of evidence, 2.MethodsPatients 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.ResultsIn 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.ConclusionThe 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.RegistrationNCT01222559 (ClinicalTrials.gov identifier).

Dataset Information

Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial.

Objective

Design

Results

Conclusions

Trial registration

Publications

Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial.

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