Using a special scaffold to treat knee osteochondritis dissecans
Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
This study is testing if a special scaffold treatment can help young people with knee osteochondritis dissecans heal better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05332288 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes of patients with osteochondritis dissecans (OCD) of the knee who receive reconstructive treatment using osteochondral scaffolds. A total of 30 patients aged 15-40 with specific OCD classifications will be monitored through clinical follow-ups and questionnaires at various intervals post-surgery. Imaging assessments, including MRI, will be conducted to evaluate cartilage repair quality over time. The study will provide insights into the effectiveness of this treatment approach in managing knee OCD defects.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 15-40 with a single symptomatic osteochondral injury from OCD classified as ICRS OCD III or IV.
Not a fit: Patients with additional cartilage injuries, advanced osteoarthritis, or systemic conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve knee function and quality of life for patients suffering from osteochondritis dissecans.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using osteochondral scaffolds have shown promise in treating cartilage defects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male or female patients, aged 15-40 years; * Single symptomatic osteochondral injury from OCD classified as ICRS OCD III or IV at the level of the femoral condyles; * Failure of conservative treatment * Lesion size between 1 and 10 cm2; * BMI ≤ 30; * Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up. Exclusion Criteria: * -Additional grade III or IV cartilage injury on the knee being treated; * Advanced osteoarthritis * Systemic or localized infection * Systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases * Immune system disorders * Degenerative or vascular bone pathology (e.g. osteonecrosis) * Coagulation disorders * Systemic conditions that alter wound healing * Established allergy to equine collagen and calcium phosphate salts * Presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously; * Previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months; * Presence of any known human immunodeficiency virus, hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; Uncontrolled diabetes; Uncontrolled thyroid function changes; Uncontrolled metabolic disorders; Renal disease and hypercalcemia * Uncooperative patients, including those with a history of alcohol and drug abuse; Participation in another clinical trial or medical device trial that clinically interferes with the present pilot study; * Incapacitated patients; * Pregnant or lactating women. In particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hCG).
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Andriolo, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Luca Andriolo, MD
- Email: luca.andriolo@ior.it
- Phone: 0516366567
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.