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

NCT ID: NCT05402072

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microfracture

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.

Group Type: ACTIVE_COMPARATOR

Autologous matrix-induced chondrogenesis (AMIC)

Intervention Type: 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.

Autologous matrix-induced chondrogenesis (AMIC)

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.

Group Type: EXPERIMENTAL

Autologous matrix-induced chondrogenesis (AMIC)

Intervention Type: 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.

Interventions

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 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.

Intervention Type: PROCEDURE

Other Intervention Names

Chondro-Gide(R)

Eligibility Criteria

Inclusion Criteria

1. All patients aged 18-55 years

2. Hip pain lasting 6 months or more with no relief from documented non-operative modalities

3. 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

4. Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination

5. Patient agrees to participate in the study-specific postoperative rehabilitation protocol

6. Patient can speak, read, and understand the language of the site

7. Patient has provided informed consent

Exclusion Criteria

1. Cartilage defects of the femoral head

2. Previous surgery on the study hip

3. Traumatic chondral injury of the hip from a single event

4. Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease

5. Known hypersensitivity or allergy to porcine collagen

6. Acute or chronic infection at the surgical site

7. Evidence of hip dysplasia (i.e., lateral centre edge angle < 20˚)

8. Evidence of acetabular over coverage such as coxa profunda or coxa protrusion

9. Immunosuppressive or anti-proliferative medication use

10. Chronic pain syndromes

11. Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))

12. History of paediatric hip disease

13. Uncontrolled diabetes

14. Contraindications to MRI imaging (e.g. claustrophobia)

15. Patient is involved in ongoing legal or workplace claims

16. Patient is incarcerated

17. Patient is pregnant or breastfeeding

18. Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up

19. Any other reason(s) the investigator feels is relevant for excluding the patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Olufemi Ayeni

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Nicole Simunovic, MSc

Role: CONTACT

simunon@mcmaster.ca

2892373224

Facility Contacts

Nicole Simunovic, MSc

Role: primary

simunon@mcmaster.ca

Other Identifiers

14981

Identifier Type: -

Identifier Source: org_study_id