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

Study Acronym: REPAIR

Ethics: Yes

Study Type: Interventional, clinical trial

Study Status: Ongoing

Study Start Date: February 22, 2023

Study Description: This is a pilot multi-centre randomized controlled trial of 40 patients (ages 18-50 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 alone 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.

Total Sample Size: 40

Primary Site: McMaster University

Primary Objective: To show feasibility of a national RCT that will evaluate the effect of AMIC compared to microfracture on patient hip function, pain, health-related quality of life (HRQL), cartilage status, and any adverse events among adult patients (18-50 years) with focal, symptomatic, articular cartilage lesions of the acetabulum. Measures of feasibility will include rates of participant enrollment and protocol adherence.

Secondary Objective: To determine in patients with focal, symptomatic, articular cartilage lesions of the acetabulum, the effect of AMIC in comparison to microfracture at 24 months post-surgery on:

  1. Hip function and HRQL as measured by the International Hip Outcome Tool (iHOT-33)

  2. Hip pain measured using a 100-point Visual Analogue Scale (VAS)

  3. Cartilage regeneration measured on MRI using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip (MERCH) score

  4. Health utility measured using the Euro-Qol 5 Dimensions (EQ-5D) questionnaire

  5. Any adverse events (including reoperations, infection, reduced range of motion, etc.)

Eligibility Criteria:

Inclusion criteria:

  1. Male and female patients aged 18-50 years

  2. Hip pain lasting 6 months or more with no relief from documented non-operative modalities

  3. 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)37 during arthroscopic examination

  4. Focal acetabular articular cartilage lesions measuring between 2x2 cm2 and 5x5 cm2 on MRI and confirmed on arthroscopic examination

  5. Patient agrees to participate in the study-specific postoperative rehabilitation protocol

  6. Patient can speak, read, and understand the language of the site

  7. Patient has provided informed consent

Exclusion criteria:

  1. Cartilage defects of the femoral head 

  2. Previous surgery on the study hip 

  3. Traumatic chondral injury of the hip from a single event

  4. Presence of advanced osteoarthritis (Tonnis grade 2 or 3)38 or any other acute or chronic inflammatory joint disease

  5. Known hypersensitivity or allergy to porcine collagen

  6. Acute or chronic infection at the surgical site

  7. Evidence of hip dysplasia (i.e., lateral centre edge angle < 20˚)

  8. Evidence of acetabular over coverage such as coxa profunda or coxa protrusion

  9. Immunosuppressive or anti-proliferative medication use

  10. Chronic pain syndromes

  11. Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))

  12. History of paediatric hip disease

  13. Uncontrolled diabetes

  14. Contraindications to MRI imaging (e.g. claustrophobia)

  15. Patient is involved in ongoing legal or workplace claims

  16. Patient is incarcerated

  17. Patient is pregnant or breastfeeding

  18. Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up

  19. Any other reason(s) the investigator feels is relevant for excluding the patient

Funding:

The budget for the REPAIR trial is as follows:

  • Chondro-Gide® product provided in-kind (i.e., at no cost)

  • $1,500 start-up fee

  • $200 per completed test case patient ($600 total for 3 test cases)

  • $850 to cover the cost of the MRI for patients at baseline, 12 months, and 24 months for a total of $2,550 for all complete study MRIs. (*Please note: a 3.0T MRI is required for this study)

  • Clinical site payments per visit: $200 each for the baseline, 6-week, and 12 and 24-month visits +$100 each for the 6-month and 18-month visits (these 2 visits can be completed remotely) for a total per patient payment of $1,000 with complete follow-up

    *All amounts are in Canadian dollars