AMIC Surgery for Hip Cartilage Injury

(REPAIR Trial)

Overseen By Nicole Simunovic, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: McMaster University

Must not be taking: Immunosuppressives, Anti-proliferatives

Disqualifiers: Advanced osteoarthritis, Hip dysplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called autologous matrix-induced chondrogenesis (AMIC) for individuals with hip cartilage damage. Researchers will compare AMIC to the standard treatment, microfracture, to determine which better improves hip function, quality of life, and reduces pain. The trial seeks participants who have experienced hip pain for at least six months, have not found relief with other treatments, and have specific types of cartilage damage confirmed by MRI. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using immunosuppressive or anti-proliferative medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that autologous matrix-induced chondrogenesis (AMIC) is generally safe for fixing cartilage problems. Studies have used a method called microfracture, which involves making tiny holes in the bone to aid healing, along with a collagen support to promote new cartilage growth. Reports indicate that patients who have undergone AMIC for similar issues, such as knee problems, have experienced good results with few serious side effects.

Some mild side effects, like temporary pain or swelling, can occur and are common for these procedures. The treatment has a good safety record, but since this is an early-stage trial for hip cartilage, ongoing research will confirm its safety and effectiveness. Researchers will closely monitor participants for any negative effects to ensure they receive the best care. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard microfracture technique, which involves creating small holes in the bone to stimulate cartilage growth, autologous matrix-induced chondrogenesis (AMIC) adds an innovative twist by incorporating a Chondro-Gide® matrix scaffold. This scaffold is tailored to fit the defect and supports the healing process by providing a structure for new cartilage to grow. Researchers are excited about AMIC because it enhances the body's natural repair mechanisms, potentially leading to better integration and durability of the repaired cartilage compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for hip cartilage injury?

Research has shown that autologous matrix-induced chondrogenesis (AMIC), a treatment participants in this trial may receive, holds promise for hip cartilage injuries. Studies have found that AMIC can significantly improve hip function and quality of life for individuals with cartilage damage. Patients have reported lasting benefits for up to five years, particularly with larger areas of damage. This trial will compare AMIC with the traditional method of microfracture, another treatment arm in the study. Comparisons indicate that AMIC might outperform microfracture by supporting cartilage healing more effectively. These findings suggest that AMIC could be an effective treatment option for those with hip cartilage problems. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I agree to follow the study's rehab plan after surgery.

Exclusion Criteria

I suffer from long-term pain.

I have cartilage damage in my hip joint.

Any other reason(s) the investigator feels is relevant for excluding the patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary hip arthroscopy with either autologous matrix-induced chondrogenesis (AMIC) or microfracture for focal articular cartilage damage

Surgery and immediate recovery

Follow-up

Participants are monitored for hip function, quality of life, hip pain, cartilage regeneration, and adverse events

24 months

Visits at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Autologous matrix-induced chondrogenesis (AMIC)

Trial Overview

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.

How Is the Trial Designed?

Group I: Autologous matrix-induced chondrogenesis (AMIC) Experimental Treatment 1 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: Microfracture Active Control 1 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.

Autologous matrix-induced chondrogenesis (AMIC) is already approved in European Union, United States for the following indications:

Approved in European Union as AMIC for:

• Focal articular cartilage defects of the hip
• Chondral lesions on the acetabulum or femoral head

Approved in United States as AMIC for:

• Cartilage repair in the hip
• Chondral defects in the acetabulum or femoral head

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Geistlich Pharma AG

Industry Sponsor

Trials

45

Recruited

2,300+

Published Research Related to This Trial

The autologous matrix-induced chondrogenesis (AMIC) technique shows promising results for knee cartilage repair, with improvements in patient-reported outcomes comparable to those seen with more established methods like autologous chondrocyte implantation (ACI).

In a review of 10 studies involving 219 patients, AMIC demonstrated effective short-term clinical outcomes and MRI results, suggesting it is a viable one-step option for cartilage restoration, though further randomized studies are needed for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Matrix-Induced Chondrogenesis in the Knee: A Review. Lee, YH., Suzer, F., Thermann, H.[2022]

Autologous matrix-induced chondrogenesis (AMIC) is an effective treatment for full-thickness cartilage defects in the knee, showing significant improvement in patient-reported outcomes over a median follow-up of 4.56 years, with benefits maintained for up to 7 years.

Patients experienced substantial reductions in pain and improvements in knee function, as measured by the Lysholm score and KOOS, with no significant impact from age, sex, or defect size on the outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Matrix-Induced Chondrogenesis for Treatment of Focal Cartilage Defects in the Knee: A Follow-up Study. Gille, J., Reiss, E., Freitag, M., et al.[2022]

The AMIC technique for treating full-thickness knee cartilage defects larger than 2 cm² resulted in significant long-term improvements in knee function, with IKDC scores increasing from 31.7 to 80.6 points and Lysholm scores from 38.8 to 72.6 points over a median follow-up of 7 years.

A majority of patients (76.2%) reported satisfaction with their outcomes, and 66.6% showed good quality repair tissue on MRI, indicating that the positive effects of the treatment were maintained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good clinical results with autologous matrix-induced chondrogenesis (Amic) technique in large knee chondral defects. Schiavone Panni, A., Del Regno, C., Mazzitelli, G., et al.[2018]

The Autologous Matrix-Induced Chondrogenesis (AMIC) technique showed significant improvement in knee function and pain reduction over a 2-year follow-up period in 57 patients with full-thickness cartilage defects, with Lysholm scores increasing from an average of 50.1 preoperatively to 85.2 at 2 years post-surgery.

Patients reported a substantial decrease in pain levels, with VAS scores dropping from 7.0 before surgery to 2.0 two years after the procedure, indicating that AMIC is both effective and safe for treating symptomatic chondral defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of Autologous Matrix Induced Chondrogenesis (AMIC) in cartilage knee surgery: data of the AMIC Registry. Gille, J., Behrens, P., Volpi, P., et al.[2022]

In a randomized controlled trial involving 41 patients, both autologous matrix-induced chondrogenesis (AMIC) and collagen-covered autologous chondrocyte implantation (ACI-C) showed significant improvement in knee function scores after 2 years, with no significant differences between the two methods.

However, two patients in the AMIC group required total knee replacement by the 2-year follow-up, while none in the ACI-C group did, suggesting a potential safety concern with AMIC that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. Fossum, V., Hansen, AK., Wilsgaard, T., et al.[2022]

In a study involving 48 patients treated with autologous matrix-induced chondrogenesis (AMIC) for cartilage damage, significant improvements in functional and subjective outcomes were observed within the first 2 years post-surgery.

The AMIC treatment demonstrated durable results specifically in patients with aligned knees, indicating its effectiveness for repairing focal chondral lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Matrix-Induced Chondrogenesis (AMIC) for Focal Chondral Lesions of the Knee: A 2-Year Follow-Up of Clinical, Proprioceptive, and Isokinetic Evaluation. Bąkowski, P., Grzywacz, K., Prusińska, A., et al.[2022]

Autologous matrix-induced chondrogenesis (AMIC) is a safe and effective treatment for full-thickness chondral and osteochondral defects in the knee, showing significant clinical improvements over a mean follow-up of 28.8 months across various outcome scores.

Patients with osteochondral defects experienced the most substantial improvements, while MRI results indicated that while tissue filling occurred, it was often incomplete and not uniform, suggesting further research is needed to compare AMIC with other cartilage repair methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of isolated chondral and osteochondral defects in the knee by autologous matrix-induced chondrogenesis (AMIC). Kusano, T., Jakob, RP., Gautier, E., et al.[2022]

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AMIC® Chondro-Gide® in the Hip

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AMIC is an innovative treatment for localized full-thickness cartilage defects combining the well-known microfracturing with collagen I/III scaffold.