Comparing AMIC and microfracture for hip cartilage damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• McMaster University
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Nicole Simunovic, MSc
• Email: simunon@mcmaster.ca
• Phone: 2892373224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.