JointRep® vs Microfracture for Knee Cartilage Repair

(JMAC Trial)

Recruiting at 7 trial locations

Overseen By Matthias Schurhoff, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oligo Medic Pty Ltd

Must not be taking: Antibiotics

Disqualifiers: BMI >35, Malalignment, Advanced musculoskeletal disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-procedure

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called JointRep® combined with microfracture, an articular cartilage repair technique, to determine if it is more effective than microfracture alone for repairing damaged knee cartilage. It targets individuals with specific knee cartilage issues that cause pain and difficulty with daily activities. Ideal participants have had an MRI or knee scope confirming cartilage damage and possess a stable knee without major ligament issues. As an unphased trial, this study provides a unique opportunity to advance knee cartilage repair techniques.

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.

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

Research has shown that treatments like JointRep® used with microfracture are generally well-tolerated. Studies have found that many patients experience significant improvement in their ability to function, with about 67% seeing better results after two years. When JointRep® is combined with microfracture, outcomes are promising, with 80% to 88% of people returning to sports. These findings suggest that both treatments are safe for many, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard microfracture procedure, which is often used to repair knee cartilage by creating small fractures to stimulate healing, JointRep® offers a unique approach by combining its application with microfracture to enhance results. Researchers are excited about JointRep® because it potentially improves the healing process by providing a scaffold that supports new cartilage growth, potentially leading to better outcomes. This combination could mean a more effective and efficient recovery for patients, offering hope for those with knee cartilage damage.

What evidence suggests that JointRep® plus microfracture could be effective for knee cartilage repair?

This trial will compare the effectiveness of JointRep® combined with microfracture surgery to microfracture surgery alone for knee cartilage repair. Research has shown that using JointRep® with microfracture surgery can be more effective than microfracture surgery alone. Studies have found that adding JointRep® improves cartilage quality, leading to better movement and function. While microfracture surgery alone has significantly helped 67% of patients after two years, adding JointRep® may speed up recovery and increase the chances of returning to sports, with success rates between 80% and 88%. This suggests that JointRep® could enhance the healing of knee cartilage injuries. ^{1 3 4 5 6}

Who Is on the Research Team?

Bruce Caldwell, MBBS, FRACS

Principal Investigator

Lingard Private Hospital

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• JointRep®
• Microfracture

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

JointRep® plus microfracture

Group II: Control Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Oligo Medic Pty Ltd

Lead Sponsor

Trials

1

Recruited

190+

Mobius Medical Pty Ltd.

Industry Sponsor

Trials

4

Recruited

250+

Published Research Related to This Trial

Microfracture surgery for isolated, full-thickness cartilage defects in the shoulder joint resulted in significant improvements in pain and shoulder function, as evidenced by a decrease in visual analog scale (VAS) scores and improvements in the Simple Shoulder Test (SST) and American Shoulder and Elbow Score (ASES) after an average follow-up of 27.8 months.

Out of 16 patients, 92.3% reported they would choose to undergo the procedure again, indicating a high level of patient satisfaction, although further long-term studies are needed to assess the durability of these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes after microfracture of the glenohumeral joint. Frank, RM., Van Thiel, GS., Slabaugh, MA., et al.[2022]

Microfracture surgery for knee cartilage repair led to significant functional improvements in 67% of patients after at least two years, with better outcomes linked to good repair-tissue fill and lower body-mass index.

Patients with a body-mass index over 30 kg/m² and those with longer preoperative symptom durations experienced poorer outcomes, highlighting the importance of these factors in predicting recovery success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chondral resurfacing of articular cartilage defects in the knee with the microfracture technique. Surgical technique. Mithoefer, K., Williams, RJ., Warren, RF., et al.[2022]

Microfracture surgery for knee cartilage repair led to significant functional improvement in 67% of patients after at least two years, with better outcomes linked to good repair-tissue fill and lower body-mass index.

Patients with a body-mass index over 30 kg/m² experienced worse results, and those with symptoms lasting less than twelve months before surgery had more frequent improvements in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. Mithoefer, K., Williams, RJ., Warren, RF., et al.[2022]

In a study of 20 patients with femoroacetabular impingement, microfracture surgery for hip cartilage defects resulted in an average of 96% fill with good quality repair tissue after 17 months, indicating its efficacy in the hip joint.

Histological analysis showed that the repair tissue was primarily fibrocartilage, with some areas exhibiting type II collagen, suggesting a positive biological response to the microfracture technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfracture for acetabular chondral defects in patients with femoroacetabular impingement: results at second-look arthroscopic surgery. Karthikeyan, S., Roberts, S., Griffin, D.[2022]

The microfracture technique, developed by the senior author and performed on over 1800 patients, enhances the body's natural healing by creating small perforations in the subchondral bone, which releases stem cells and growth factors to promote cartilage repair.

Successful rehabilitation following microfracture surgery is essential, as it helps create the optimal conditions for stem cells to transform into cartilage-like cells, leading to durable repair of cartilage defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfracture: surgical technique and rehabilitation to treat chondral defects. Steadman, JR., Rodkey, WG., Rodrigo, JJ.[2022]

Microfracture is effective for improving knee function in the short term (up to 24 months) after treatment, based on a systematic review of 28 studies involving 3122 patients.

However, the long-term durability of these improvements is uncertain, with variability in cartilage repair quality and functional outcomes, indicating a need for more rigorous studies to assess its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. Mithoefer, K., McAdams, T., Williams, RJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04840147

A Comparison of JointRep® and Microfracture in Repair ... The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/13696998.2022.2078574

Cost-effectiveness analysis of arthroscopic injection of a ... The key benefit of JointRep is that it improves the quality of life of patients by improving the quality of the articular cartilage and hence the function of ...

3. withpower.com withpower.com/trial/phase-fractures-stress-3-2021-3c7d2

JointRep® vs Microfracture for Knee Cartilage Repair Microfracture surgery for knee cartilage repair led to significant functional improvement in 67% of patients after at least two years, with better outcomes ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12437190/

Investigating Outcomes in Knee Cartilage Restoration ... Appropriate intervention with chondral defects is often performed to prevent early development of arthritis and the need for joint replacement.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667254524000155

New horizons in cartilage repair: update on treatment ... Studies have consistently shown excellent clinical outcomes, with return-to-sports rates ranging from 80% to 88%.100, 101 Furthermore, studies investigating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8488240/

Articular cartilage repair & joint preservation: A review of the ... This is an up to date concise review discussing the available management options for articular cartilage damage starting to lifestyle modification.