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NCT Number: NCT05402072

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

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.

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Key information

Conditions

Hip Arthroscopy Articular Cartilage Defect Fractures, Bone Fractures, Stress Microfractures Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location status: Recruiting

Location contact

Nicole Simunovic, MSc

CONTACT

[email protected]

Olufemi R. Ayeni, MD, PhD, FRCSC

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Chondro-Gide(R)

Primary outcomes

  1. 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

    The iHOT-33 is designed to measure hip-specific health-related quality of life changes after treatment of active young patients with hip disorders. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.

Secondary outcomes

  1. Hip pain using the Visual Analogue Scale (VAS); 100-point scale

    Time frame: Change from baseline to 24 months post-surgery

    To measure hip pain. The total score is calculated as a single response ranging from 0 to 100, with 100 representing the worst possible pain.

  2. 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

    To evaluate cartilage repair in the hip using MRI imaging. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 0 representing the worst cartilage status.

  3. Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score

    Time frame: Change from baseline to 24 months post-surgery

    Utility-based instrument for use as a measure of health outcome. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

  4. Total number of adverse events

    Time frame: 24 months post-surgery

    Any reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, and reduced range of motion

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Simunovic, MSc

CONTACT

[email protected]

2892373224

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Geistlich Pharma AG

Registry information

Official study title

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

Acronym: REPAIR

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 2, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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