Loading clinical trials...

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

RECRUITINGNA

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

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.

NCT04840147•Oligo Medic Pty Ltd

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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
+20 more criteria

Locations (8)

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

Cairns Orthopaedic Clinic

Parramatta Park, Queensland, Australia

North Queensland Knee

Pimlico, Queensland, Australia

Melbourne Orthopedic Group

Melbourne, Victoria, Australia

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Key Dates

Start Date

September 22, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 20, 2024

Enrollment

185

ESTIMATED participants

Conditions

Chondral DefectArticular Cartilage DefectArticular Cartilage Disorder of Knee

Interventions

JointRep®

DEVICE

Microfracture

PROCEDURE

Contacts

Matthias Schurhoff, MD

CONTACT

+13054919070 mschurhoff@oligomedic.com

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

NCT06915233

Chondral DefectArticular Cartilage Defect

View study

RECRUITING

Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear

NCT03909139

Acetabular Labrum TearFemoro Acetabular Impingement+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear

BioPoly® Partial Resurfacing Knee Implant IDE

Knee Registry (Knieregister)

Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)