RecruitingPhase 1NCT05402072

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

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

Sponsor

McMaster University

Enrollment

40 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Hip arthroscopy Articular Cartilage Defect Microfractures

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

All patients aged 18-55 years
Hip pain lasting 6 months or more with no relief from documented non-operative modalities
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
Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
Patient agrees to participate in the study-specific postoperative rehabilitation protocol
Patient can speak, read, and understand the language of the site
Patient has provided informed consent

Exclusion Criteria19

Cartilage defects of the femoral head
Previous surgery on the study hip
Traumatic chondral injury of the hip from a single event
Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
Known hypersensitivity or allergy to porcine collagen
Acute or chronic infection at the surgical site
Evidence of hip dysplasia (i.e., lateral centre edge angle < 20˚)
Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
Immunosuppressive or anti-proliferative medication use
Chronic pain syndromes
Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
History of paediatric hip disease
Uncontrolled diabetes
Contraindications to MRI imaging (e.g. claustrophobia)
Patient is involved in ongoing legal or workplace claims
Patient is incarcerated
Patient is pregnant or breastfeeding
Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
Any other reason(s) the investigator feels is relevant for excluding the patient

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Interventions

PROCEDUREAutologous matrix-induced chondrogenesis (AMIC)

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.