JointRep® vs Microfracture for Knee Cartilage Repair

(JMAC Trial)

Recruiting at7 trial locations

Overseen by Bruce Caldwell, MBBS, FRACS

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. ^{1 2 3 4 5}

How 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. ^{1 2 3 5 6}

Research Team

Bruce Caldwell, MBBS, FRACS

Principal Investigator

Lingard Private Hospital

Eligibility 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.

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.

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

Treatment Details

Interventions

• JointRep® (Implant)
• Microfracture (Procedure)

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.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

JointRep® plus microfracture

Group II: Control Experimental Treatment 1 Intervention

Microfracture alone

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Chondral resurfacing of articular cartilage defects in the knee with the microfracture technique. Surgical technique. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Microfracture for acetabular chondral defects in patients with femoroacetabular impingement: results at second-look arthroscopic surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Microfracture: surgical technique and rehabilitation to treat chondral defects. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes after microfracture of the glenohumeral joint. [2022]