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A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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)

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.

Exclusion criteria

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-09-22

Primary completion: 2025-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

Trial ID

NCT04840147

Intervention or treatment

DEVICE: JointRep®

PROCEDURE: Microfracture

Conditions

• Chondral Defect
• Articular Cartilage Defect
• Articular Cartilage Disorder of Knee

Condition: Chondral Defect, Articular Cartilage Defect and more
DEVICE: JointRep® and other drugs
Deakin, Australian Capital Territory, Australia and more
Sponsor: Oligo Medic Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Canberra Orthopaedics and Sports Medicine

Research sites nearby

Select from list below to view details:

Canberra Orthopaedics and Sports Medicine
Deakin, Australian Capital Territory, Australia
Sydney Knee Specialists
Kogarah, New South Wales, Australia
Lingard Private Hospital
Newcastle, New South Wales, Australia
Orthosports
Randwick, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention JointRep® plus microfracture	DEVICE: 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.
OTHER: Control Microfracture alone	PROCEDURE: Microfracture 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intervention

JointRep® plus microfracture

DEVICE: 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.

OTHER: Control

Microfracture alone

PROCEDURE: Microfracture

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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Lesion fill.	Percentage of lesion fill measured by 3D quantitative Magnetic Resonance Imaging (qMRI).	24-months post procedure.

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Visual Analogue Scale.	Pain score in treated knee using the visual analogue scale from 0(no pain) to 10 (worst pain imaginable) .	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.	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).	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.	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.	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) .	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).	6 and 12 and 24-months post procedure.
Safety as Adverse Events related to the procedure	Evaluation of adverse events.	Baseline to 24-months post procedure.

Frequently Asked Questions

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References

Clinical Trials Gov: A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,