Comparing AMIC and microfracture for hip cartilage damage

Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial

This study is testing whether a new treatment called AMIC works better than microfracture for helping people with hip cartilage damage feel better and improve their quality of life after surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT05402072 on ClinicalTrials.gov

What this trial studies

This pilot multi-centre randomized controlled trial involves 40 patients aged 18-55 who are undergoing primary hip arthroscopy due to focal articular cartilage defects of the acetabulum. The study aims to compare the effectiveness of autologous matrix-induced chondrogenesis (AMIC) versus microfracture in improving hip function, quality of life, and cartilage regeneration over a two-year follow-up period. Patients will be assessed at multiple intervals post-surgery to evaluate pain, health utility, and any adverse events.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-55 with persistent hip pain and confirmed focal articular cartilage defects.

Not a fit: Patients with cartilage defects of the femoral head or advanced osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with hip cartilage damage, potentially leading to improved recovery and quality of life.

How similar studies have performed: Other studies have shown promising results with similar cartilage repair techniques, suggesting potential for success in this approach.

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 allergy to porcine collagen
6. Acute or chronic infection at the surgical site
7. Evidence of hip dysplasia (i.e., lateral centre edge angle \< 20˚)
8. Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
9. Immunosuppressive or anti-proliferative medication use
10. Chronic pain syndromes
11. Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
12. History of paediatric hip disease
13. Uncontrolled diabetes
14. Contraindications to MRI imaging (e.g. claustrophobia)
15. Patient is involved in ongoing legal or workplace claims
16. Patient is incarcerated
17. Patient is pregnant or breastfeeding
18. Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
19. Any other reason(s) the investigator feels is relevant for excluding the patient

Where this trial is running

Hamilton, Ontario

• McMaster University — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Nicole Simunovic, MSc

Conditions Hip Arthroscopy; Articular Cartilage Defect; Microfractures