Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
NCT05402072

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

Led by McMaster University · Updated on 2025-09-24

40

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

Sponsors

M

McMaster University

Lead Sponsor

G

Geistlich Pharma AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 to 55 years
  • Hip pain lasting 6 months or more with no relief from non-operative treatments
  • Full-thickness focal articular cartilage defects of the acetabulum confirmed by MRI and arthroscopy (ICRS grade 3 or 4)
  • Cartilage lesions measuring between 3 cm2 and 25 cm2 confirmed by MRI and arthroscopy
  • Agreement to participate in the study-specific postoperative rehabilitation
  • Ability to speak, read, and understand the site language
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Cartilage defects on the femoral head
  • Previous surgery on the study hip
  • Traumatic chondral injury of the hip from a single event
  • Advanced osteoarthritis (Tonnis grade 3) or other inflammatory joint disease
  • Allergy or hypersensitivity to porcine collagen
  • Infection at the surgical site
  • Hip dysplasia (lateral centre edge angle < 20°)
  • Acetabular over coverage such as coxa profunda or coxa protrusion
  • Use of immunosuppressive or anti-proliferative medication
  • Chronic pain syndromes
  • Significant medical conditions requiring help with daily living
  • History of pediatric hip disease
  • Uncontrolled diabetes
  • Contraindications to MRI (e.g., claustrophobia)
  • Ongoing legal or workplace claims
  • Incarceration
  • Pregnancy or breastfeeding
  • Likely difficulty maintaining follow-up as judged by investigator
  • Other reasons deemed relevant by the investigator for exclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

McMaster University

Hamilton, Ontario, Canada, L8N3Z5

Actively Recruiting

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Research Team

N

Nicole Simunovic, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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