Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
McMaster University
RECRUITING
Hamilton
Contact Information
Primary
Nicole Simunovic, MSc
simunon@mcmaster.ca
2892373224
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Microfracture
As per current standard of care for focal articular cartilage lesions of the acetabulum, the unstable cartilage will be debrided and removed from the subchondral bone using a mechanical shaver until a stable margin is obtained. A ring curette will be used to remove the calcified cartilage layer and create a border of healthy cartilage tissue that can support the marrow clot. Through the mid-anterior portal, specialized 90˚ awls will then be placed with the tip perpendicular to the subchondral bone of the acetabulum, and a mallet will be used to penetrate the subchondral bone with perforations 3 mm deep to access the bone marrow elements. This is done until the defect is homogeneously covered with micro-perforations 2-3 mm apart.
Experimental: Autologous matrix-induced chondrogenesis (AMIC)
Those allocated to the AMIC treatment group will also receive microfracture. Once the walls of the debrided lesion are confirmed to be stable with a probe, the exact size of the defect will be measured for templating of the scaffold. The dry Chondro-Gide® matrix will be prepared by cutting it to 10% smaller than the focal defect (as it increases in size about 10% after moistening). Once the cartilage lesion is dried manually, the implant will then be secured to the defect in a press-fit fashion to the surrounding cartilage. Manual pressure is then applied to secure the implant into the defect and the hip is released from traction and rotated to facilitate further fixation of the graft. Traction is then applied to arthroscopically confirm position and fixation of the implant.
Related Therapeutic Areas
Sponsors
Collaborators: Geistlich Pharma AG
Leads: McMaster University

This content was sourced from clinicaltrials.gov