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

NCT05402072 | Recruiting Phase 1

• 1 other identifier: 14981
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Arthroscopy; Articular Cartilage Defect; Microfractures

Outcome Measures

Primary Outcomes (1)

• Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)

  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.

  Change from baseline to 24 months post-surgery

Secondary Outcomes (4)

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

  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)

  Change from baseline to 24 months post-surgery

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

  Change from baseline to 24 months post-surgery

• Total number of adverse events

  24 months post-surgery

Study Arms (2)

Microfracture

ACTIVE COMPARATOR

As per current standard of care for focal articular cartilage lesions of the acetabulum, the unstable cartilage will be debrided and removed from the subchondral bone using a mechanical shaver until a stable margin is obtained. A ring curette will be used to remove the calcified cartilage layer and create a border of healthy cartilage tissue that can support the marrow clot. Through the mid-anterior portal, specialized 90˚ awls will then be placed with the tip perpendicular to the subchondral bone of the acetabulum, and a mallet will be used to penetrate the subchondral bone with perforations 3 mm deep to access the bone marrow elements. This is done until the defect is homogeneously covered with micro-perforations 2-3 mm apart.

Procedure: Autologous matrix-induced chondrogenesis (AMIC)

Autologous matrix-induced chondrogenesis (AMIC)

EXPERIMENTAL

Those allocated to the AMIC treatment group will also receive microfracture. Once the walls of the debrided lesion are confirmed to be stable with a probe, the exact size of the defect will be measured for templating of the scaffold. The dry Chondro-Gide® matrix will be prepared by cutting it to 10% smaller than the focal defect (as it increases in size about 10% after moistening). Once the cartilage lesion is dried manually, the implant will then be secured to the defect in a press-fit fashion to the surrounding cartilage. Manual pressure is then applied to secure the implant into the defect and the hip is released from traction and rotated to facilitate further fixation of the graft. Traction is then applied to arthroscopically confirm position and fixation of the implant.

Procedure: Autologous matrix-induced chondrogenesis (AMIC)

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.

Also known as: Chondro-Gide(R)

Autologous matrix-induced chondrogenesis (AMIC); Microfracture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Central Study Contacts

Nicole Simunovic, MSc

CONTACT

2892373224; simunon@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessors, those performing data entry and analysis, and patients will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All patients presenting to each clinical site's out-patient fracture clinics and/or sports medicine subspecialty clinics between ages of 18 and 5 years with a symptomatic chondral injury of the hip will be screened. There will be a Research Coordinator on hand during the initial phase of the surgery for each consented patient, where the surgeon will assess the final aspects of eligibility. If eligibility is confirmed, the Research Coordinator will randomize the patient using a centralized 24-hour online randomization system that will follow a randomization schedule in random block sizes of 4 and 8. The secure online randomization system will ensure concealment of the treatment allocation. If the surgeon deems intra-operatively that the subject does not meet the inclusion criteria, the surgeon will manage the lesion as per the normal standard of care and the subject's ineligibility will be recorded on the screening form.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: March 13, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)