Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study (MAIOCD)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Osteochondritis Dissecans Knee

Study type: Observational

Funder types: Other

Identifiers

NCT05332288

MAIOCD

Details and patient eligibility

About

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.

Full 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 surgery and at 6, 12, 24 and 60 months after surgery. A CRF (Case Report Form) related to the patient's specific evaluation will be completed for each visit. Patients will also have imaging (MRI) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. Evaluation of the quality of cartilage repair will be assessed by specific MRI radiographic scores.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and 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).