NCT06238947

Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial

LONG-TERM EVALUATION OF OUTCOMES OF PATIENTS UNDERGOING AUTOLOGOUS CHONDROCYTE TRANSPLANTATION DELIVERED ON BIOMATERIAL (HYALOGRAFT C) Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Chondro-Long study is prospective observational study for a long-term clinical evaluation (follow-up up to 25 years) in patients treated with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) at the level of femoral condyles, trochlea, patella and tibial plateau. The aim of the study is to collect long-term clinical data from the case series of patients surgically treated from 1999 to 2006 with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) or osteochondral defects at the level of femoral condyles, trochlea, patella, and tibial plateau. The objective of the study is to demonstrate the efficacy of this long-term cartilage regeneration technique (follow-up up to 25 years) in improving patient symptomatology and functional capacity

Detailed description

Patients will be recruited from all subjects surgically treated with autologous chondrocyte transplantation delivered on biomaterial for chondral/osteochondral lesions at the femoral condyles, trochlea, patella, and tibial plateau from 1999 to 2006 at the Rizzoli Orthopaedic Institute. The study has 3 phases: Identification of includable patients, Follow-up assessment byTelemedicine platform, and the collection of study-specific clinical data of enrolled patients. Clinical score data will be collected from the medical records and questionnaires conducted in the mid-term of patients enrolled in the study. These data will be used, together with data collected by telemedicine/long-term e-mail questionnaire, to evaluate the time course of outcomes after surgical treatment with autologous chondrocyte transplantation delivered on biomaterial

Conditions

• Cartilage Injury
• Cartilage Disease

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-02-02
• Last updated: 2026-02-03