JointRep® vs Microfracture for Knee Cartilage Repair
(JMAC Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oligo Medic Pty Ltd
Must not be taking: Antibiotics
Disqualifiers: BMI >35, Malalignment, Advanced musculoskeletal disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing whether using JointRep® gel along with a microfracture procedure is better at repairing knee cartilage damage than using microfracture alone. The study focuses on patients with specific knee cartilage issues. The microfracture technique helps new cartilage grow, and JointRep® provides a supportive environment for this growth. Researchers will measure how well the new cartilage forms and its quality over time. JointRep is a bioadhesive hydrogel arthroscopically injected to facilitate cartilage regeneration.
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 does exclude those currently using antibiotics. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment JointRep® for knee cartilage repair?
The microfracture technique, which is part of the study, is a well-known method for repairing knee cartilage by creating small holes in the bone to stimulate healing. It has been used in over 1800 patients and helps the body form new cartilage-like tissue, although detailed long-term effectiveness data is limited.
12345How does the JointRep® treatment differ from other treatments for knee cartilage repair?
JointRep® is a novel treatment for knee cartilage repair that is being compared to the microfracture technique, which involves creating small holes in the bone to stimulate healing. Unlike microfracture, which relies on the body's natural healing process, JointRep® may offer a different mechanism or approach, but specific details about its uniqueness are not provided in the available research.
12356Eligibility Criteria
This trial is for adults aged 18-65 with one or two specific types of knee cartilage damage, totaling no more than 10cm2. Participants must have a stable knee, not be pregnant or planning pregnancy within a year, and able to follow the study's procedures. Exclusions include severe health conditions, high BMI (>35), recent other treatments on the knee, drug/alcohol abuse, and allergies to shellfish.Inclusion Criteria
I am willing and able to follow all study and recovery procedures.
I have 1 or 2 severe knee cartilage damages not larger than 10cm2 in total.
My knee problem was confirmed by MRI or arthroscopy in the last 6 months.
+7 more
Exclusion Criteria
Are participating concurrently in another clinical investigation, or have participated in a clinical investigation within the last 90 days, or intend to participate in another clinical investigation during the course of the study
Are currently breastfeeding or planning to breastfeed any time during the course of the study
I have a blood clotting disorder.
+19 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either JointRep® plus microfracture or microfracture alone for cartilage repair
Immediate post-procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 24 months
24 months
Multiple visits at 3, 6, 12, and 24 months
Interim Analysis
Interim analysis of primary and secondary endpoints at 12 months
12 months
Participant Groups
The study tests if JointRep® combined with microfracture surgery is better than just microfracture surgery for treating certain types of painful cartilage lesions in the knee. It involves comparing outcomes between these two approaches in patients randomly assigned to each group.
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
JointRep® plus microfracture
Group II: ControlExperimental Treatment1 Intervention
Microfracture alone
JointRep® is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as JointRep for:
- Chondropathies (cartilage defects)
- Osteoarthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth General HospitalDartmouth, Canada
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Who Is Running the Clinical Trial?
Oligo Medic Pty LtdLead Sponsor
Mobius Medical Pty Ltd.Industry Sponsor
References
The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. [2022]Microfracture is a frequently used technique for the repair of articular cartilage lesions of the knee. Despite the popularity of the technique, prospective information about the clinical results after microfracture is still limited. The purpose of our study was to identify the factors that affect the clinical outcome from this cartilage repair technique.
Chondral resurfacing of articular cartilage defects in the knee with the microfracture technique. Surgical technique. [2022]Microfracture is a frequently used technique for the repair of articular cartilage lesions of the knee. Despite the popularity of the technique, prospective information about the clinical results after microfracture is still limited. The purpose of our study was to identify the factors that affect the clinical outcome from this cartilage repair technique.
Microfracture for acetabular chondral defects in patients with femoroacetabular impingement: results at second-look arthroscopic surgery. [2022]Microfracture is a proven technique to treat articular cartilage defects in the knee. However, there is little evidence in the literature to confirm the ability of microfracture to produce repair tissue in the hip joint.
Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. [2022]Despite the popularity of microfracture as a first-line treatment for articular cartilage defects in the knee, systematic information on its clinical efficacy for articular cartilage repair and long-term improvement of knee function is not available.
Microfracture: surgical technique and rehabilitation to treat chondral defects. [2022]Full-thickness articular cartilage defects rarely heal spontaneously. Some patients may not have clinically significant problems from chondral defects, but most eventually have degenerative changes. Techniques to treat chondral defects include abrasion, drilling, autografts, allografts, and cell transplantation. The senior author (JRS) developed the microfracture technique to enhance chondral resurfacing by providing a suitable environment for new tissue formation and taking advantage of the body's own healing potential. Microfracture has been done in more than 1800 patients. Specially designed awls are used to make multiple perforations, or microfractures, into the subchondral bone plate. Perforations are made as close together as possible, but not so close that one breaks into another. They usually are approximately 3 to 4 mm apart. The integrity of the subchondral bone plate must be maintained. The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced super clot that provides an enriched environment for new tissue formation. The rehabilitation program is crucial to optimize the results of the surgery. It promotes the ideal physical environment for the marrow mesenchymal stem cells to differentiate into articular cartilagelike cells, ultimately leading to development of a durable repair cartilage that fills the original defect.
Clinical outcomes after microfracture of the glenohumeral joint. [2022]Microfracture is an effective surgical treatment for isolated, full-thickness cartilage defects with current data focused on applications in the knee. No studies describing clinical outcomes of patients who have undergone microfracture in the shoulder joint have been reported.