Status:
RECRUITING
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Geistlich Pharma AG
Conditions:
Hip Arthroscopy
Articular Cartilage Defect
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 usin...
Eligibility Criteria
Inclusion
- All patients aged 18-55 years
- Hip pain lasting 6 months or more with no relief from documented non-operative modalities
- 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
- Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
- Patient agrees to participate in the study-specific postoperative rehabilitation protocol
- Patient can speak, read, and understand the language of the site
- Patient has provided informed consent
Exclusion
- Cartilage defects of the femoral head
- Previous surgery on the study hip
- Traumatic chondral injury of the hip from a single event
- Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
- Known hypersensitivity or allergy to porcine collagen
- Acute or chronic infection at the surgical site
- Evidence of hip dysplasia (i.e., lateral centre edge angle \< 20˚)
- Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
- Immunosuppressive or anti-proliferative medication use
- Chronic pain syndromes
- Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
- History of paediatric hip disease
- Uncontrolled diabetes
- Contraindications to MRI imaging (e.g. claustrophobia)
- Patient is involved in ongoing legal or workplace claims
- Patient is incarcerated
- Patient is pregnant or breastfeeding
- Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
- Any other reason(s) the investigator feels is relevant for excluding the patient
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05402072
Start Date
March 13 2023
End Date
January 1 2027
Last Update
September 24 2025
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5