AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMcMaster University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Autologous matrix-induced chondrogenesis (AMIC)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
McMaster University
Lead sponsor
Geistlich Pharma AG
Collaborator
Source ClinicalTrials.gov