Using a special scaffold to treat knee osteochondritis dissecans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.