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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

Must not have

Chronic pain syndromes

Cartilage defects of the femoral head

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I suffer from long-term pain.

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I have cartilage damage in my hip joint.

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My hip socket covers the ball of my hip more than it should.

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My diabetes is not under control.

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I have had surgery on my hip that is part of the study.

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I need help with daily activities due to other health issues.

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I am taking medication that affects my immune system or controls cell growth.

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I have a hip injury from a single accident.

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I have severe arthritis or another type of joint inflammation.

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I have an infection at the site of my upcoming surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Cartilage repair using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip Score (MERCH) (scored from 0-100)

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

Hip structure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 14Eligibility criteria met