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Recruiting NCT05402072

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

Phase I Interventional Hip Arthroscopy Articular Cartilage Defect Microfractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous matrix-induced chondrogenesis (AMIC).
Who it may be relevant to
Registry conditions: Hip Arthroscopy, Articular Cartilage Defect, Microfractures. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Procedure Autologous 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 impa

Primary outcome measures

  • Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33) [Time frame: Change from baseline to 24 months post-surgery]
Secondary outcome measures (4)
  • Hip pain using the Visual Analogue Scale (VAS); 100-point scale [Time frame: Change from baseline to 24 months post-surgery]
  • Cartilage repair using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip Score (MERCH) (scored from 0-100) [Time frame: Change from baseline to 24 months post-surgery]
  • Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score [Time frame: Change from baseline to 24 months post-surgery]
  • Total number of adverse events [Time frame: 24 months post-surgery]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • McMaster University — Hamilton

Identifiers

NCT: NCT05402072 · 14981

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗