AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip (NCT05402072) | Clinical Trial Compass
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Canada40 participantsStarted 2023-03-13
Plain-language 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.
Who can participate
Age range18 Years โ 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
โ. All patients aged 18-55 years
โ. Hip pain lasting 6 months or more with no relief from documented non-operative modalities
โ. 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
โ. Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
โ. Patient agrees to participate in the study-specific postoperative rehabilitation protocol
โ. Patient can speak, read, and understand the language of the site
โ. Patient has provided informed consent
Exclusion criteria
โ. Cartilage defects of the femoral head
โ. Previous surgery on the study hip
โ. Traumatic chondral injury of the hip from a single event
โ. Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
โ. Known hypersensitivity or allergy to porcine collagen
โ. Acute or chronic infection at the surgical site
What they're measuring
1
Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)
Timeframe: Change from baseline to 24 months post-surgery