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

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ClinicalTrials.gov Identifier: NCT05402072
Recruitment Status : Not yet recruiting
First Posted : June 2, 2022
Last Update Posted : June 2, 2022
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Olufemi Ayeni, McMaster University

Brief Summary:
This is a pilot multi-centre RCT of 30 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.

Condition or disease Intervention/treatment Phase
Hip Arthroscopy Articular Cartilage Defect Microfractures Procedure: Autologous matrix-induced chondrogenesis (AMIC) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients presenting to each clinical site's out-patient fracture clinics and/or sports medicine subspecialty clinics between ages of 18 and 40 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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The outcome assessors, those performing data entry and analysis, and patients will be blinded to the treatment allocation.
Primary Purpose: Treatment
Official Title: Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2027

Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Chondro-Gide(R)

Experimental: 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.
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.
Other Name: Chondro-Gide(R)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale (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 100 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05402072


Contacts
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Contact: Nicole Simunovic, MSc 2892373224 simunon@mcmaster.ca

Sponsors and Collaborators
McMaster University
Geistlich Pharma AG
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Responsible Party: Olufemi Ayeni, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT05402072    
Other Study ID Numbers: 14981
First Posted: June 2, 2022    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries