New scaffold could help repair knee damage in young adults
NCT ID NCT05332288
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing a special scaffold designed to help repair damaged knee cartilage in people with osteochondritis dissecans. The scaffold is implanted during surgery to support new tissue growth. Researchers will follow 30 patients aged 15-40 to see how their knee symptoms, sports ability, and function improve over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- triphasic osteochondral scaffold
- What this could lead to
- If successful, this could show that the scaffold helps repair knee cartilage, potentially improving pain and mobility for people with this condition.
- What could go wrong
- This is a small observational study with no control group, so results may not prove the scaffold is better than other treatments. Risks include surgical complications or the scaffold not integrating well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with knee OCD (ICRS OCD 3-4) with surgical indication for treatment of these lesions by biological reconstructive technique with osteochondral scaffolds will be enrolled. The estimated number of patients enrolled is 30, of which we expect from epidemiological data that about one third (10 patients) are between 15 and 18 years old.
- Ages
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15 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istituto Ortopedico Rizzoli
RECRUITINGBologna, 40136, Italy
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