Chondral DefectJMACNCT04840147
A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,
A study testing JointRep® and Microfracture in people with Chondral Defect and Articular Cartilage Defect, run by Oligo Medic Pty Ltd at 8 sites in 2 countries.
Trial summary
The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chondral Defect, Articular Cartilage Defect, Articular Cartilage Disorder of Knee
- What is being tested?
- JointRep® and Microfracture
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 22 Sep 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18-65 years old
- 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 1-7cm2. If more than one lesion is present, the sum of the two lesions should not exceed 10cm2.
- Within 6 months prior to treatment, have a Magnetic Resonance Imaging (MRI) or arthroscopic confirmation of lesion(s) in the index knee.
- For patients older than 40 y.o, to have a radiological Kellgren and Lawrence (K\&L) grading from a standing knee radiograph taken less than 6 months previously, Grade 1 or
- If not, an actual test will be performed as part of the visit 1 procedures.
- 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)
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- Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- VAS pain great than or equal to 4 in the last week.
- Be willing and able to comply with all study procedures including all preoperative, post-operative and rehabilitation requirements
- If female and of child-bearing potential, must report double-barrier, contraceptive use (e.g. use of birth-control pill and condom) for at least 2 months prior to treatment and in the 12 months following treatment.
- If female and of child-bearing potential, have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the 12 months following treatment.
Who cannot join
- Have a Body Mass Index (BMI) >35kg/m2
- Have more than two lesions (ICRS grade 3 or 4A) on any surface in the index knee
- Have "kissing" or opposing lesion(s) (ICRS grade 3 or 4A) of the condyle, tibia or patella in the index knee; additional linear lesions which bear Grade 3 or 4 characteristics may be acceptable if they are determined by the Investigator to be incidental, not clinically relevant, and consistent with the subject demographic
- Have malalignment of >5 degrees varus or valgus in the index knee based on standard AP x-rays requiring an osteotomy
- Have had any surgical treatment for cartilage repair in the index knee within 1 year prior to treatment
- Have had intra-articular injections within 3 months in the index knee
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- Have a diagnosis of a concomitant knee injury which may confound assessment of the index knee (e.g., important meniscal injury)
- Have significant pain emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) limb.
- Have known allergies to shellfish
- Have a known history of crystalloid or inflammatory arthropathy
- Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica)
- Have advanced musculoskeletal disease
- Have active coagulation disorders
- Are currently using antibiotics
- 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 abusing drugs or alcohol or have a history of the same within the last 12 months
- Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
- Are currently breastfeeding or planning to breastfeed any time during the course of the study
- Are currently a prisoner
- Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)
- Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation
- Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance
- Intra-operative Exclusion Criteria:
- Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
- Have lesion(s) in the index knee that are not contained (intact shoulders) and/or exceed 7 cm² in total size after debridement for a single lesion and 10cm2 for more than one lesion, if within the same condyle or the trochlea. If only a single lesion suitable to be included is identified, it might be between 1-7cm2.
- Minor concomitant procedures are allowed such as, but not limited to:
- Removal of loose bodies
- Plica excision
- Minor synovial removing
- Minor chondroplasty (debridement)
- Lysis of adhesions
- Meniscal trimming/suturing which respects the exclusion criteria.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia7 sites, 6 recruiting
- Recruiting
Canberra Orthopaedics and Sports Medicine
Deakin, Australian Capital Territory
Mark Porter, MBBS, FRACS
Mark Porter, MBBS, FRACS
- Active, not recruiting
Sydney Knee Specialists
Kogarah, New South Wales
- Recruiting
Melbourne Orthopedic Group
Melbourne, Victoria
Timothy Lording, MBBS, FRACS
Timothy Lording, MBBS, FRACS
- Recruiting
Lingard Private Hospital
Newcastle, New South Wales
Bruce Caldwell, MBBS, FRACS
- Recruiting
Cairns Orthopaedic Clinic
Parramatta Park, Queensland
Ben Parkinson, MBBS, FRACS
Ben Parkinson, MBBS, FRACS
- Recruiting
North Queensland Knee
Pimlico, Queensland
Peter McEwen, MBBS, FRACS
Peter McEwen, MBBS, FRACS
- Recruiting
Orthosports
Randwick, New South Wales
Doron Sher, MBBS, FRACS
Doron Sher, MBBS, FRACS
Canada1 site, 1 recruiting
- Recruiting
Dartmouth General Hospital
Dartmouth, Nova Scotia, B2Y 4G8
Jasmine Boudreau, jsmnboudreau@gmail.com
Nathan Urquhart, MD, FRCSC
About this study
Official title: A Randomized, Controlled, Comparative, Single-blinded, Multi-center Study Evaluating JointRep® and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle or Trochlea, The JMAC Trial.
The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).
Read the detailed description
The aim of the JMAC study, an international multicenter Randomized Controlled Trial, is to assess the effectiveness and safety of JointRep®, a second-generation chitosan-based hydrogel for cartilage repair. A total of 185 subjects will be randomized 2:1 to either Microfracture plus JointRep® or Microfracture alone. The follow up will be at 24 months, with a planned interim analysis at 12 months. The primary endpoint is an objectively measured structural one (quantity of new cartilaginous tissue, assessing the percentage of fill) and it will be blindly assessed using a quantitative MRI at 12 and 24 months. Two of the secondary endpoints are also structurally based and blindly measured: quality of the new tissue, quantifying the T2 (which measures the Collagen 2 content and orientation as well as degree of hydration); the upper and lower half of the new tissue T2 measurement will depict the degree of stratification of the new cartilaginous tissue. A semiquantitative MOCART-2 blinded analysis will also be carried out. The clinical outcomes will be measured using KOOS and Tegner, as well as a VAS and an EQ-5 questionnaire. All the secondary endpoints will be analyzed at the same 12 and 24 months timepoints. In addition, subject safety will be assessed through a record of adverse events.
- Being tested
- JointRep®, Microfracture
- Keywords
- Bone Marrow Stimulation, Microfracture, Matrix Augmented Bone Marrow Stimulation, Chitosan
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JointRep®Device
JointRep® is a medical device based on a thermogel polymer (Chitosan) for the treatment of chondral lesions, which consists of an injectable aqueous composition that forms a solid and sticky hydrogel in situ within cartilage defect(s). JointRep® is composed of an injectable thermo-gelling aqueous composition. It is used in conjunction with a Bone Marrow Stimulation type of procedure like Microfracture.
MicrofractureProcedure or surgery
Also called Bone Marrow Stimulation
Microfracture is a bone marrow stimulation type of procedure where after debridement of the damaged chondral tissue within the lesion, obtention of stable vertical margins and curettage of the entire calcified layer, multiple holes are created with a variety of instruments (awls, picks, microdills, nanofracture) to establish a communication with the subchondral bone to create a blood clot to elicit the natural healing process
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | JointRep® plus microfracture Receives: Device: JointRep®; Procedure: Microfracture |
| Control | Other | Microfracture alone Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion fill.
Percentage of lesion fill measured by 3D quantitative Magnetic Resonance Imaging (qMRI).
Measured: 24-months post procedure.
Secondary outcomes (8)
Visual Analogue Scale.
Pain score in treated knee using the visual analogue scale from 0(no pain) to 10 (worst pain imaginable) .
Measured: Baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.
T2 scores.
Difference in quantitative T2 scores between investigational subjects and control subjects measured by qMRI.
Measured: 12 and 24-months post procedure.
Treatment failure.
Proportion of subjects who do not experience a treatment failure and achieve ≥80% lesion fill (success rate).
Measured: 24-months post procedure.
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Knee Injury and Osteoarthritis Outcome Score (pain, function, symptoms, sports/recreation and quality of life). 100 indicates no problems and 0 indicates extreme problems.
Measured: 6 and 12 and 24-months post procedure.
Tegner Activity Scale
Tegner activity scale provides a level of activity and is scored between 0 and 10. Level 0 is the worst activity level and Level 10 is the best activity level.
Measured: 6 and 12 and 24-months post procedure.
Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 (MOCART-2) score.
MOCART-2 score ranges form 0 (worst outcome) to 100 (best outcome) .
Measured: 6 and 12 and 24-months post procedure.
Euro Quality of Life-5D (EQ-5D) instrument for measuring quality of life.
EuroQol-5D (EQ-5D) instrument for measuring quality of life has two parts. The first assesses health in five parts (mobility, self-care, usual activity, pain/discomfort, anxiety depression) with each scored form 1 (best outcome) to 5 (worst outcome). The second part consists of a visual analogue scale rating perceived health form 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: 6 and 12 and 24-months post procedure.
Safety as Adverse Events related to the procedure
Evaluation of adverse events.
Measured: Baseline to 24-months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start22 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oligo Medic Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mobius Medical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Bruce Caldwell, MBBS, FRACS, Principal investigator, Lingard Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840147
- Sponsor's protocol ID
- JR001PMAUS01-2020
- Acronym
- JMAC
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Comparative, Single-blinded, Multi-center Study Evaluating JointRep® and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle or Trochlea, The JMAC Trial.
- ClinicalTrials.gov ID
- NCT04840147
- Acronym / sponsor ID
- JMAC / JR001PMAUS01-2020
- Keywords
- Bone Marrow Stimulation, Microfracture, Matrix Augmented Bone Marrow Stimulation, Chitosan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Oligo Medic Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Mobius Medical Pty Ltd.
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).
Detailed description
The aim of the JMAC study, an international multicenter Randomized Controlled Trial, is to assess the effectiveness and safety of JointRep®, a second-generation chitosan-based hydrogel for cartilage repair. A total of 185 subjects will be randomized 2:1 to either Microfracture plus JointRep® or Microfracture alone. The follow up will be at 24 months, with a planned interim analysis at 12 months. The primary endpoint is an objectively measured structural one (quantity of new cartilaginous tissue, assessing the percentage of fill) and it will be blindly assessed using a quantitative MRI at 12 and 24 months. Two of the secondary endpoints are also structurally based and blindly measured: quality of the new tissue, quantifying the T2 (which measures the Collagen 2 content and orientation as well as degree of hydration); the upper and lower half of the new tissue T2 measurement will depict the degree of stratification of the new cartilaginous tissue. A semiquantitative MOCART-2 blinded analysis will also be carried out. The clinical outcomes will be measured using KOOS and Tegner, as well as a VAS and an EQ-5 questionnaire. All the secondary endpoints will be analyzed at the same 12 and 24 months timepoints. In addition, subject safety will be assessed through a record of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: JointRep®, Procedure: MicrofractureJointRep® plus microfracture |
| Control | Other | Procedure: MicrofractureMicrofracture alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be between 18-65 years old
- 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 1-7cm2. If more than one lesion is present, the sum of the two lesions should not exceed 10cm2.
- Within 6 months prior to treatment, have a Magnetic Resonance Imaging (MRI) or arthroscopic confirmation of lesion(s) in the index knee.
- For patients older than 40 y.o, to have a radiological Kellgren and Lawrence (K\&L) grading from a standing knee radiograph taken less than 6 months previously, Grade 1 or
- If not, an actual test will be performed as part of the visit 1 procedures.
Key exclusion criteria (32 listed)
- Have a Body Mass Index (BMI) >35kg/m2
- Have more than two lesions (ICRS grade 3 or 4A) on any surface in the index knee
- Have "kissing" or opposing lesion(s) (ICRS grade 3 or 4A) of the condyle, tibia or patella in the index knee; additional linear lesions which bear Grade 3 or 4 characteristics may be acceptable if they are determined by the Investigator to be incidental, not clinically relevant, and consistent with the subject demographic
- Have malalignment of >5 degrees varus or valgus in the index knee based on standard AP x-rays requiring an osteotomy
- Have had any surgical treatment for cartilage repair in the index knee within 1 year prior to treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JointRep®JointRep® is a medical device based on a thermogel polymer (Chitosan) for the treatment of chondral lesions, which consists of an injectable aqueous composition that forms a solid and sticky hydrogel in situ within cartilage defect(s). JointRep® is composed of an injectable thermo-gelling aqueous composition. It is used in conjunction with a Bone Marrow Stimulation type of procedure like Microfracture. | Device | Intervention |
| MicrofractureAlso: Bone Marrow StimulationMicrofracture is a bone marrow stimulation type of procedure where after debridement of the damaged chondral tissue within the lesion, obtention of stable vertical margins and curettage of the entire calcified layer, multiple holes are created with a variety of instruments (awls, picks, microdills, nanofracture) to establish a communication with the subchondral bone to create a blood clot to elicit the natural healing process | Procedure or surgery | Control, Intervention |
Primary outcome
Lesion fill.
Time frame: 24-months post procedure.
Percentage of lesion fill measured by 3D quantitative Magnetic Resonance Imaging (qMRI).
8 secondary outcomes
Visual Analogue Scale.
Time frame: Baseline and then at 3-months, 6-months, 12-months and 24-months post procedure.
T2 scores.
Time frame: 12 and 24-months post procedure.
Treatment failure.
Time frame: 24-months post procedure.
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 6 and 12 and 24-months post procedure.
Tegner Activity Scale
Time frame: 6 and 12 and 24-months post procedure.
Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 (MOCART-2) score.
Time frame: 6 and 12 and 24-months post procedure.
Euro Quality of Life-5D (EQ-5D) instrument for measuring quality of life.
Time frame: 6 and 12 and 24-months post procedure.
Safety as Adverse Events related to the procedure
Time frame: Baseline to 24-months post procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Caldwell, MBBS, FRACS principal investigator
Lingard Private Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JointRep® and Microfracture in people with Chondral Defect and Articular Cartilage Defect, run by Oligo Medic Pty Ltd at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Schurhoff, MD (+13054919070, mschurhoff@oligomedic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion fill. (time frame: 24-months post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.