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AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

Recruiting
18-55 years
All
Phase 1

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Overview

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

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

Study details
    Hip Arthroscopy
    Articular Cartilage Defect
    Microfractures

NCT05402072

McMaster University

25 June 2024

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