Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteochondritis Dissecans Knee
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- IKDC-Subjective Score
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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;
Outcomes
Primary Outcomes
IKDC-Subjective Score
Time Frame: 24 months
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function
Secondary Outcomes
- IKDC-Subjective Score(baseline, 6 months, 12 months, 60 months)
- IKDC-Objective Score(baseline, 6 months, 12 months, 24 months, 60 months)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 6 months, 12 months, 24 months, 60 months)
- TegnerActivity Level Scale(baseline, 6 months, 12 months, 24 months, 60 months)
- Patient Acceptable Symptom State (PASS(baseline, 6 months, 12 months, 24 months, 60 months)
- KOOS Score(baseline, 6 months, 12 months, 24 months, 60 months)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score(12 months, 24 months, 60 months)