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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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. Who Should NOT Join This Trial: - -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 weakened immune system 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Locations (1)

Istituto Ortopedico Rizzoli
Bologna, Italy