Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study (NCT05332288) | Clinical Trial Compass
RecruitingNot Applicable
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Italy30 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range
15 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.