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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)
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
JMAC Trial Summary
This trial will compare the effectiveness of two procedures for treating symptomatic focal articular cartilage lesions in the knee.
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.Check my eligibility
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.See study design
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).
JMAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1 or 2 severe knee cartilage damages not larger than 10cm2 in total.
Select...
My knee is stable, with no major ligament issues and mostly intact meniscal rims.
Select...
I am between 18 and 65 years old.
Select...
My pain level has been 4 or higher in the past week.
JMAC Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lesion fill.
Secondary outcome measures
Euro Quality of Life-5D (EQ-5D) instrument for measuring quality of life.
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 (MOCART-2) score.
+5 moreJMAC Trial Design
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
JointRep® plus microfracture
Group II: ControlExperimental Treatment1 Intervention
Microfracture alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Microfracture
2002
Completed Phase 3
~1180
Find a Location
Who is running the clinical trial?
Oligo Medic Pty LtdLead Sponsor
Mobius Medical Pty Ltd.Industry Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
Bruce Caldwell, MBBS, FRACSPrincipal InvestigatorLingard Private Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study and recovery procedures.I have a blood clotting disorder.I have had injections in my knee joint within the last 3 months.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.I have a history of joint inflammation or crystal-related joint issues.I have a condition other than my knee issue that affects my ability to walk.My condition involves advanced bone or muscle issues.My knee has more than two severe lesions.I am using two forms of birth control and will continue for 12 months after treatment.I have serious health issues that make surgery risky.I am not pregnant and do not plan to become pregnant in the next year.I have another knee injury that could affect the assessment of my main knee issue.You have a mental or psychological disorder that would make it difficult for you to answer the study questionnaires.You are allergic to shellfish.My knee is stable, with no major ligament issues and mostly intact meniscal rims.My knee has severe cartilage damage that touches or opposes another damaged area.I do not have any health issues that would stop me from attending follow-up visits or doing post-op rehab.I am over 40 and have a recent knee X-ray showing mild arthritis.I have not had knee surgery for cartilage repair in the past year.I am between 18 and 65 years old.I have significant pain in my hips, knees, or ankles.You are currently using drugs or alcohol excessively, or have done so in the past year.My knee is misaligned by more than 5 degrees and needs surgery.I am currently taking antibiotics.My pain level has been 4 or higher in the past week.My BMI is over 35.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals eligible to join this research endeavor?
"As per the requirements for participation, all volunteers must be between 18 and 65 years of age."
Answered by AI
How many test subjects are participating in this experiment?
"Affirmative. The information available on clinicaltrials.gov points to this medical study actively recruiting patients, with the initial post being dated September 22nd 2021 and most recent update occurring 8th of September 2022. This trial requires 185 participants from a single site."
Answered by AI
Is there still capacity for individuals to participate in this experiment?
"Confirmed. According to the clinicaltrials.gov listing, this research is actively seeking participants and has been since September 22nd 2021. The most recent update occurred on 8th of September 2022 with a total of 185 patients sought from one single location."
Answered by AI
Who meets the requirements for participation in this study?
"To qualify for this trial, applicants must be aged 18-65 and present with chondral defects. A total of 185 participants will be admitted to the clinical study."
Answered by AI
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