AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

Launched by MCMASTER UNIVERSITY · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical techniques to treat damage to the cartilage in the hip joint for patients aged 18 to 55 years. The researchers want to find out which method works better: autologous matrix-induced chondrogenesis (AMIC) or microfracture. Both techniques aim to improve hip function, reduce pain, and help the cartilage heal over a period of two years. Participants will have follow-up visits at six weeks, six months, one year, one and a half years, and two years after their surgery to monitor their progress.

To be eligible for the study, patients must have had hip pain for at least six months that hasn't improved with other treatments. They should have a specific type of cartilage damage confirmed by MRI and during surgery. However, certain conditions like previous surgeries on the hip, severe arthritis, or infections would disqualify a person from participating. If someone joins the study, they will follow a special rehabilitation program after their surgery. Overall, this trial aims to find the most effective way to help patients recover from hip cartilage damage and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. All patients aged 18-55 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) during arthroscopic examination
• • 4. Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 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 3) 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