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

Hip Arthroscopy Clinical Trial

— REPAIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402072
• Other study ID #: 14981
• Status: Recruiting
• Phase: Phase 1
• Start date: March 13, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Nicole Simunovic, MSc
• Phone: 2892373224
• Email: simunon[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot multi-centre RCT of 40 patients (ages 18-40 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Male and female patients aged 18-40 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)37 during arthroscopic examination

4. Focal acetabular articular cartilage lesions measuring between 2x2 cm2 and 5x5 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 2 or 3)38 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

Related Conditions & MeSH terms

• Articular Cartilage Defect
• Fractures, Stress
• Hip Arthroscopy
• Microfractures

Intervention

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 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Geistlich Pharma AG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hip pain using the Visual Analogue Scale (VAS); 100-point scale	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.	Change from baseline to 24 months post-surgery
Secondary	Cartilage repair using the Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale (scored from 0-100)	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 100 representing the worst cartilage status.	Change from baseline to 24 months post-surgery
Secondary	Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score	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.	Change from baseline to 24 months post-surgery
Secondary	Total number of adverse events	Any reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, and reduced range of motion	24 months post-surgery