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

Primary Purpose

Hip Arthroscopy, Articular Cartilage Defect, Microfractures

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Autologous matrix-induced chondrogenesis (AMIC)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthroscopy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Microfracture

Autologous matrix-induced chondrogenesis (AMIC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Total number of adverse events
Any reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, and reduced range of motion

Full Information

First Posted
May 25, 2022
Last Updated
March 13, 2023
Sponsor
McMaster University
Collaborators
Geistlich Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT05402072
Brief Title
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Acronym
REPAIR
Official Title
Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Geistlich Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthroscopy, Articular Cartilage Defect, Microfractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
The outcome assessors, those performing data entry and analysis, and patients will be blinded to the treatment allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microfracture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Autologous matrix-induced chondrogenesis (AMIC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous matrix-induced chondrogenesis (AMIC)
Other Intervention Name(s)
Chondro-Gide(R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)
Description
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.
Time Frame
Change from baseline to 24 months post-surgery
Secondary Outcome Measure Information:
Title
Hip pain using the Visual Analogue Scale (VAS); 100-point scale
Description
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.
Time Frame
Change from baseline to 24 months post-surgery
Title
Cartilage repair using the Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale (scored from 0-100)
Description
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.
Time Frame
Change from baseline to 24 months post-surgery
Title
Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score
Description
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.
Time Frame
Change from baseline to 24 months post-surgery
Title
Total number of adverse events
Description
Any reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, and reduced range of motion
Time Frame
24 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients aged 18-40 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)37 during arthroscopic examination Focal acetabular articular cartilage lesions measuring between 2x2 cm2 and 5x5 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 Exclusion Criteria: 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 2 or 3)38 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 Patient is incarcerated Patient is pregnant or breastfeeding Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up Any other reason(s) the investigator feels is relevant for excluding the patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Simunovic, MSc
Phone
2892373224
Email
simunon@mcmaster.ca
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Simunovic, MSc
Email
simunon@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Olufemi R. Ayeni, MD, PhD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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