AMIC Surgery for Hip Cartilage Injury
(REPAIR Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: McMaster University
Must not be taking: Immunosuppressives, Anti-proliferatives
Disqualifiers: Advanced osteoarthritis, Hip dysplasia, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This is a pilot multi-centre RCT of 40 patients (ages 18-55 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.
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.
What data supports the effectiveness of the treatment Autologous Matrix-Induced Chondrogenesis (AMIC) for hip cartilage injury?
Research shows that AMIC is effective for treating cartilage defects in the knee, with good clinical results maintained over several years. This suggests it may also be beneficial for similar cartilage issues in the hip.
12345Is AMIC surgery generally safe for treating cartilage defects?
AMIC surgery, which combines microfracture surgery with a collagen membrane, has been studied for knee cartilage defects and shows good clinical results over several years, suggesting it is generally safe for humans.
13567How is the AMIC treatment for hip cartilage injury different from other treatments?
AMIC is unique because it combines microfracture, a technique that creates small holes in the bone to stimulate healing, with a collagen scaffold that helps stabilize the area and support new cartilage growth. This one-step approach is different from other treatments that may require multiple procedures or do not use a scaffold to aid in cartilage repair.
12357Eligibility Criteria
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.
+4 more
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
+16 more
Trial Timeline
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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McMaster UniversityHamilton, Canada
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Who Is Running the Clinical Trial?
McMaster UniversityLead Sponsor
Geistlich Pharma AGIndustry Sponsor
References
Good clinical results with autologous matrix-induced chondrogenesis (Amic) technique in large knee chondral defects. [2018]Label="PURPOSE" NlmCategory="OBJECTIVE">Autologous matrix-induced chondrogenesis (AMIC) is a treatment for focal full-thickness cartilage defects combining microfracturing with an exogenous I/III collagen matrix (Chondro-Gide). The aim of the present study was to determine the 7 years outcomes of patients treated with the AMIC technique for knee chondral defects larger than 2 cm2. The hypothesis was that the positive short-term outcomes achieved in the previous series would not deteriorate at a 7-year follow-up.
Outcome of Autologous Matrix Induced Chondrogenesis (AMIC) in cartilage knee surgery: data of the AMIC Registry. [2022]Autologous Matrix-Induced Chondrogenesis (AMIC) is an innovative treatment for localized full-thickness cartilage defects combining the well-known microfracturing with collagen I/III scaffold. The purpose of this analysis was to evaluate the medium-term results of this enhanced microfracture technique for the treatment of chondral lesions of the knee.
Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee. [2022]Autologous matrix-induced chondrogenesis (AMIC) is a single-stage alternative to autologous chondrocyte implantation for treatment of localized cartilage defects of the knee. To our knowledge, no randomized controlled trial exists comparing the 2 methods.
Treatment of isolated chondral and osteochondral defects in the knee by autologous matrix-induced chondrogenesis (AMIC). [2022]The purpose of this study is to evaluate clinical and radiological outcomes of patients treated with autologous matrix-induced chondrogenesis (AMIC) for full-thickness chondral and osteochondral defects of the femoral condyles and patella.
Autologous Matrix-Induced Chondrogenesis for Treatment of Focal Cartilage Defects in the Knee: A Follow-up Study. [2022]Autologous matrix-induced chondrogenesis (AMIC) is a well-established treatment for full-thickness cartilage defects.
Autologous Matrix-Induced Chondrogenesis (AMIC) for Focal Chondral Lesions of the Knee: A 2-Year Follow-Up of Clinical, Proprioceptive, and Isokinetic Evaluation. [2022](1) Background: The autologous matrix-induced chondrogenesis (AMIC) is a bio-orthopedic treatment for articular cartilage damage. It combines microfracture surgery with the application of a collagen membrane. The aim of the present study was to report a medium-term follow-up of patients treated with AMIC for focal chondral lesions. (2) Methods: Fourty-eight patients treated surgically and 21 control participants were enrolled in the study. To evaluate the functional outcomes, the proprioceptive (postural stability, postural priority) and isokinetic (peak value of maximum knee extensor and flexor torque in relation to body mass and the total work) measurements were performed. To evaluate the clinical outcomes, the Lysholm score and the IKDC score were imposed. (3) Results: Compared to the preoperative values, there was significant improvement in the first 2 years after intervention in the functional as well as subjective outcome measures. (4) Conclusions: AMIC showed durable results in aligned knees.
Autologous Matrix-Induced Chondrogenesis in the Knee: A Review. [2022]Autologous matrix-induced chondrogenesis (AMIC) is a 1-step cartilage restoration technique that combines microfracture with the use of an exogenous scaffold. This matrix covers and mechanically stabilizes the clot. There have been an increasing number of studies performed related to the AMIC technique and an update of its use and results is warranted.