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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
185
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.
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
Canberra Orthopaedics and Sports Medicine
Deakin, Australian Capital Territory, Australia
RECRUITINGSydney Knee Specialists
Kogarah, New South Wales, Australia
ACTIVE_NOT_RECRUITINGLingard Private Hospital
Newcastle, New South Wales, Australia
Lesion fill.
Percentage of lesion fill measured by 3D quantitative Magnetic Resonance Imaging (qMRI).
Time frame: 24-months post procedure.
Visual Analogue Scale.
Pain score in treated knee using the visual analogue scale from 0(no pain) to 10 (worst pain imaginable) .
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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) .
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Orthosports
Randwick, New South Wales, Australia
RECRUITINGCairns Orthopaedic Clinic
Parramatta Park, Queensland, Australia
RECRUITINGNorth Queensland Knee
Pimlico, Queensland, Australia
RECRUITINGMelbourne Orthopedic Group
Melbourne, Victoria, Australia
RECRUITINGDartmouth General Hospital
Dartmouth, Nova Scotia, Canada
RECRUITINGTime frame: 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).
Time frame: 6 and 12 and 24-months post procedure.
Safety as Adverse Events related to the procedure
Evaluation of adverse events.
Time frame: Baseline to 24-months post procedure.