Actively Recruiting
Autologous Matrix-Induced Chondrogenesis Compared With Microfracture for Focal Articular Cartilage Damage of the Hip A Pilot Randomized Controlled Trial
Led by McMaster University · Updated on 2025-09-24
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
G
Geistlich Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two surgical treatments for people aged 18 to 55 years undergoing primary hip arthroscopy due to a focal cartilage defect in the acetabulum. It is a pilot randomized controlled trial assessing the effects of autologous matrix-induced chondrogenesis (AMIC) versus microfracture on hip function, quality of life, pain, cartilage repair, and health utility over two years. The study follows participants for 24 months with scheduled check-ins at 6 weeks, 6 months, 12 months, 18 months, and 24 months after surgery. During surgery, all participants will have unstable cartilage removed and microfracture performed by making small holes in the bone to encourage healing. Those in the AMIC group will also receive a collagen matrix implant placed over the cartilage defect to support tissue repair. This matrix is secured precisely and checked arthroscopically to ensure proper placement. Both treatments are done during the same surgical procedure. Participants will attend follow-up visits at set intervals over two years to assess their hip function using the International Hip Outcome Tool (iHOT-33) and other measures such as pain, cartilage repair via MRI scoring, health status, and any adverse events. Researchers will monitor changes from before surgery to 24 months afterward to evaluate the treatments' effects. The trial is led by McMaster University and includes detailed assessments to understand outcomes and safety.
CONDITIONS
Brief Title
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 55 years
- Hip pain lasting 6 months or more without relief from non-surgical treatments
- Focal full-thickness acetabular cartilage defects confirmed by MRI and arthroscopy (ICRS grade 3 or 4)
- Cartilage lesions measuring between 3 cm2 and 25 cm2
- Agreement to participate in study-specific postoperative rehabilitation
- Ability to speak, read, and understand the language of the study site
- Provided informed consent
You will not qualify if you...
- Cartilage defects on the femoral head
- Previous surgery on the study hip
- Traumatic chondral injury from a single event
- Advanced osteoarthritis (Tonnis grade 3) or inflammatory joint diseases
- Allergy to porcine collagen
- Acute or chronic infection at the surgical site
- Hip dysplasia or acetabular overcoverage conditions
- Use of immunosuppressive or anti-proliferative medications
- Chronic pain syndromes or significant medical co-morbidities affecting daily living
- History of pediatric hip disease
- Uncontrolled diabetes
- Contraindications to MRI (e.g., claustrophobia)
- Involvement in legal or workplace claims
- Incarceration
- Pregnancy or breastfeeding
- Likely difficulty maintaining follow-up
- Any other investigator-determined reasons for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with post-operative rehabilitation
Participants receive surgical treatment either with microfracture alone or microfracture enhanced by a collagen matrix implant (AMIC) to repair focal articular cartilage damage in the hip.
1 baseline visit and multiple follow-up visits during rehabilitation
Duration - Up to 24 months post-surgery
Participants are monitored for hip function, pain, cartilage repair, and adverse events for up to 24 months after surgery.
Periodic follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Actively Recruiting
Research Team
N
Nicole Simunovic, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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