REPAIR: AMIC vs Microfracture for Acetabular Cartilage Defects of Hip
Research type
Research Study
Full title
Autologous MatRix-Induced ChondrogenEsis ComPared with Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomised Controlled Trial
IRAS ID
326268
Contact name
Ajay Malviya
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Articular cartilage lesions in the hip caused by excessive wear and tear (e.g. sporting activity); hip pathologies such as femoroacetabular impingement (FAI) (a mismatch between the femoral head (ball) and acetabulum (socket) causing both structures to collide during hip movement); or early osteoarthritis can cause pain and poor function in young adults. In these patients, we do not have a predictable treatment to relieve pain and halt the progression of arthritis. The current best treatment for these lesions is microfracture, but the repaired material may not be as durable as native cartilage. However, a new treatment called autologous matrix-induced chondrogenesis (AMIC) involves using a collagen-based patch over the blood clot formed after microfracture, which can help develop repair tissue similar to pre-existing cartilage. The collagen patch protects the cells and minimises disruption to the blood clot while providing an environment for cell growth, and is eventually replaced by native tissue.
This pilot study aims to determine in individuals aged 18-40 years with full-thickness acetabular cartilage defects, the effect of AMIC, using microfracture topped with a collagen patch (Chondro-Gide® Geistlich Pharma AG), in comparison to microfracture alone (standard of care). All participants will be identified, screened, consented to, and randomised to either treatment in a high-volume specialist centre in the North-East of England. Patients' general health, quality of life, pain levels, hip function, and cartilage-specific outcome measures will be collected using surveys and magnetic resonance imaging (MRI) scans over 24 months following surgery. This pilot study will also determine the feasibility of recruiting patients and following them throughout their recovery and completing all necessary questionnaires. Measures of feasibility will include rates of participant enrolment and adherence to protocol. If this pilot study is successful, the study results will inform a larger definitive international multicentre randomised controlled trial.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0147
Date of REC Opinion
23 Aug 2023
REC opinion
Favourable Opinion