Evaluating results of knee cartilage transplants
Study Protocol for a Prospective Observational Study to Evaluate the Clinical and Imaging Results of the Fresh Osteochondral Allograft Transplantation for Osteochondral Knee Lesions
This study is testing how well knee cartilage transplants work for people with large knee injuries by looking at their recovery and using imaging techniques over 15 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT04236492 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical and imaging outcomes of fresh osteochondral allograft transplantation in patients with large osteochondral defects in the knee. It involves a prospective, patient-centered approach where participants will be monitored from baseline to 15 months post-surgery, using various patient-reported outcome measures and imaging techniques like MRI and CT. The study will also explore variations based on additional factors such as age, sex, and other demographic information.
Who should consider this trial
Good fit: Ideal candidates are young patients with large focal full-thickness chondral and osteochondral defects greater than 2 cm² in specific areas of the knee.
Not a fit: Patients with a BMI over 30, systemic inflammatory diseases, advanced osteoarthritis, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with significant knee cartilage damage.
How similar studies have performed: Other studies have shown promising results with similar approaches to osteochondral allograft transplantation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients undergoing cartilage repair with fresh osteochondral allograft transplantation for large focal full-thickness chondral and osteochondral defects (\>2 cm2) on the tibial plateau, femoral condyles, trochlea and/or patella Bipolar lesions are included. Exclusion Criteria: * BMI\> 30 kg / m2 * Systemic inflammatory diseases * Inflammatory arthritis * Advanced osteoarthritis * Tricompartmental degenerative process * Active infection * Patients who are unable to provide written informed consent.
Where this trial is running
Barcelona, Catalonia
- Hospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Pablo Gelber — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study coordinator: Àlex Grau Blanes
- Email: agraub@santpau.cat
- Phone: +34935537031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.