Actively Recruiting
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-23
30
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 0 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).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
L
Luca Andriolo, MD
CONTACT
R
Roberta Licciardi, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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