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Procedure

AMIC Surgery for Hip Cartilage Injury (REPAIR Trial)

Phase 1

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 (ICRS grade 3 or 4) during arthroscopic examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-surgery

Awards & highlights

REPAIR Trial Summary

This trial tests a new hip surgery technique to improve hip pain, mobility, quality of life and cartilage regeneration. 40 patients aged 18-40 will be followed up for 2 years.

Who is the study for?

This trial is for men and women aged 18-40 with hip pain from a specific type of cartilage damage in the hip socket, confirmed by MRI and surgery. They must have struggled with this pain for at least six months without relief from non-surgical treatments. Participants need to be able to follow the post-op rehab plan, understand the local language, give informed consent, and not have any conditions that exclude them like previous hip surgeries or certain medical issues.Check my eligibility

What is being tested?

The study compares two surgical techniques for repairing damaged hip cartilage: autologous matrix-induced chondrogenesis (AMIC) versus microfracture. It aims to assess which method better improves hip function, quality of life, pain reduction, and cartilage regeneration over two years with check-ups every few months.See study design

What are the potential side effects?

Potential side effects may include typical surgical risks such as infection or adverse reactions to materials used in AMIC (like porcine collagen), complications from anesthesia, prolonged recovery times compared to expectations, or failure of the procedure leading to continued pain or need for additional surgery.

REPAIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had hip pain for over 6 months without relief from non-surgical treatments.

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My MRI shows full thickness cartilage defects in my hip joint.

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I am between 18 and 40 years old.

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My hip joint cartilage damage is confirmed by MRI and surgery to be between 2x2 and 5x5 cm.

REPAIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Cartilage repair using the Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale (scored from 0-100)

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

Hip structure

+1 more

REPAIR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Autologous matrix-induced chondrogenesis (AMIC)Experimental Treatment1 Intervention

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 II: MicrofractureActive Control1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,276 Total Patients Enrolled

Geistlich Pharma AGIndustry Sponsor

41 Previous Clinical Trials

2,036 Total Patients Enrolled

Media Library

Autologous matrix-induced chondrogenesis (AMIC) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05402072 — Phase 1

$Hip Arthroscopy Research Study Groups: Microfracture, Autologous matrix-induced chondrogenesis (AMIC)$

Hip Arthroscopy Clinical Trial 2023: Autologous matrix-induced chondrogenesis (AMIC) Highlights & Side Effects. Trial Name: NCT05402072 — Phase 1

Autologous matrix-induced chondrogenesis (AMIC) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05402072 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Autologous matrix-induced chondrogenesis (AMIC) present any potential dangers to patients?

"Autologous matrix-induced chondrogenesis (AMIC) has minimal safety and efficacy data, so it scored a 1 on our risk assessment scale."

Answered by AI

Does this research accept participants aged eighty and over?

"This clinical trial seeks participants aged 18 to 40. Separately, there are 9 trials for minors and 24 for senior citizens."

Answered by AI

Are there still opportunities available to participate in this clinical investigation?

"Affirmative. Clinicaltrials.gov reveals that this experiment, first made available on March 13th 2023, is currently enrolling individuals. 40 volunteers are needed from a single research site."

Answered by AI

What is the magnitude of participants enrolled in this investigation?

"Affirmative. Information found on clinicaltrials.gov reveals that this experiment, which was first announced on March 13th 2023, is presently recruiting applicants. Approximately 40 participants need to be enlisted from 1 study centre."

Answered by AI

Are there any qualifications for individuals to take part in this investigation?

"This clinical trial is seeking 40 individuals aged between 18 and 40 who have recently undergone a hip arthroscopy. To be eligible, male and female patients must present with at least 6 months of pain not remedied by non-operative modalities, possess International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4 articular cartilage defects measuring 2 to 5 cm2 as seen on MRI scans, agree to the study's rehabilitation protocol, comprehend the language in which this research is conducted, and provide an informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Olufemi Ayeni 2023. "AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05402072.