RecruitingNCT05332288
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
30 participants
Start Date
Apr 1, 2022
Study Type
OBSERVATIONAL
Conditions
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 evaluation will be performed through clinical, subjective and objective assessments.
Eligibility
Min Age: 15 YearsMax Age: 40 Years
Inclusion Criteria6
- 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 Criteria15
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05332288