RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: McMaster University • ClinicalTrials.gov ID: NCT05402072

Registry updated: 2026-10-07

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Autologous matrix-induced chondrogenesis (AMIC) (Procedure)
AMIC is a novel approach in which the microfracture technique has been enhanced by the use of a type I/III collagen matrix (Chondro-Gide®; Geistlich Pharma AG, Wolhusen, Switzerland). In this single-step procedure, the matrix is placed over the defect to stabilize the fragile blood clot that arises from microfracture and to provide infrastructure for repair tissue formation. Essentially, the matrix covers the defect and serves as a protective shield that contains the cells and minimizes the impact of shear forces when moving the hip on the delicate blood clot. At the same time, it functions as the roof of a biological chamber that forms over the defect. The biocompatible collagen material provides an environment for cell growth and is replaced by native tissue over time.

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

Conditions

Hip Arthroscopy Articular Cartilage Defect Microfractures

Locations

McMaster University — Hamilton, Ontario, Canada

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment