Status:
RECRUITING
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteochondritis Dissecans Knee
Eligibility:
All Genders
15-40 years
Brief Summary
The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The ...
Detailed Description
30 patients affected by OCD of the knee will be included in observational, perspective, monocentric trial. Patients will undergo clinical follow-up visits and administration of questionnaires before s...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05332288
Start Date
April 1 2022
End Date
April 1 2029
Last Update
September 23 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136