Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063315) titled 'Prediction of Postoperative Outcomes and Ultra-Long-Term Degeneration after Matrix-Associated Autologous Chondrocyte Implantation (MACI) using Artificial Intelligence' on Oct. 16.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Shimane University

Condition: Condition - Traumatic cartilage defect, Osteochondritis dissecanse of the knee, knee osteoarthritis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The goal of this study is to build predictive models for postoperative outcomes and ultra-long-term degradation patterns using machine learning and time-series deep learning algorithms for patients who underwent autologous cultured cartilage implantation (MACI) for knee joint cartilage defects. To overcome the ceiling effects in traditional evaluation criteria, we first calculate the clinical threshold (cutoff value) of MOI (Maximal Outcome Improvement) using the anchor method from our own institution's data. Next, we apply this threshold to a large-scale post-marketing registry in Japan (RWD) to determine whether each case achieved MOI or not. Finally, by constructing a machine learning model (such as LightGBM) with 'MOI achievement or failure' as the target variable, we analyze the factors influencing MOI achievement in domestic real-world data from multiple angles. This lays the foundation for a personalized shared decision-making (SDM) support system that can suggest the optimal surgical procedure or the necessity of combined surgeries (such as high tibial osteotomy [HTO]) based on preoperative patient background. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 10 years-old

Gender - Male and Female Key inclusion criteria - Patients who underwent autologous cultured cartilage implantation: MACI for knee cartilage defects at the Orthopedic Surgery Department of Shimane University Hospital between January 1, 1996, and December 31, 2025. Those from whom appropriate verbal consent by phone was obtained to use their medical information and interview data for this study. Those who have clinical scores; Lysholm score, KOOS score, Forgotten Joint Score12 recorded preoperatively and postoperatively (at any time from 1 month after surgery to the final follow-up). Those who provided answers to the anchor question in the phone survey, either "If a similar cartilage injury were found in your current knee and the doctor recommended the same 'cultured cartilage implantation,' would you want to undergo this surgery again?: Willingness for repeat surgery, primary analysis" or "Considering all daily activities, pain level, and physical function limitations, are you satisfied with your current condition? : Satisfaction, secondary analysis", or both. Patients who were aged 10 years or older and 70 years or younger at the time of surgery. Key exclusion criteria - 1) Those with an active joint infection in the same knee. 2) Those with severe inflammatory joint diseases, such as advanced rheumatoid arthritis. 3) Those whose follow-up data is completely missing, making it impossible to validate the AI model. Target Size - 788

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 14 Day Date of IRB - 2026 Year 10 Month 14 Day Anticipated trial start date - 2026 Year 10 Month 19 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072467

Disclaimer: Curated by HT Syndication.