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Implant

JointRep® vs Microfracture for Knee Cartilage Repair (JMAC Trial)

N/A

Recruiting

Led By Bruce Caldwell, MBBS, FRACS

Research Sponsored by Oligo Medic Pty Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have one or two focal articular cartilage lesion(s) (ICRS Grade 3 or 4A) on the femoral condyles or trochlea of the index knee; patellar tracking must be normal if the index lesion(s) is on the trochlea. Individually, a lesion can be between 2-7cm2. If more than one lesion is present, the sum of the two lesions should not exceed 10cm2.

Have a clinically stable knee, with no ligament deficiencies (<5mm side-to-side difference on Lachman and varus/valgus stress testing & Grade 0 or 1 on Pivot shift test) and the meniscal rims are intact (a maximum of 50% resection is allowed)

Must not have

Have active coagulation disorders

Have a known history of crystalloid or inflammatory arthropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at the surgical site, swelling or stiffness in the knee joint post-operation, infection risks from surgery and allergic reactions (especially important for those with shellfish allergies due to JointRep® components).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 1 or 2 severe knee cartilage damages not larger than 10cm2 in total.

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My knee is stable, with no major ligament issues and mostly intact meniscal rims.

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I am between 18 and 65 years old.

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My pain level has been 4 or higher in the past week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I have a history of joint inflammation or crystal-related joint issues.

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I have a condition other than my knee issue that affects my ability to walk.

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My condition involves advanced bone or muscle issues.

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My knee has more than two severe lesions.

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I have significant pain in my hips, knees, or ankles.

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My knee is misaligned by more than 5 degrees and needs surgery.

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I am currently taking antibiotics.

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My BMI is over 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and then at 3-months, 6-months, 12-months and 24-months post procedure. for reporting.