NCT05402072 AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
| NCT ID | NCT05402072 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | McMaster University |
| Condition | Hip Arthroscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2026-01-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.
Eligibility Criteria
Inclusion Criteria: 1. All patients aged 18-55 years 2. Hip pain lasting 6 months or more with no relief from documented non-operative modalities 3. Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination 4. Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination 5. Patient agrees to participate in the study-specific postoperative rehabilitation protocol 6. Patient can speak, read, and understand the language of the site 7. Patient has provided informed consent Exclusion Criteria: 1. Cartilage defects of the femoral head 2. Previous surgery on the study hip 3. Traumatic chondral injury of the hip from a single event 4. Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease 5. Known hypersensitivity or alle