Clinical Trials Logo

Clinical 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04840147
Study type Interventional
Source Oligo Medic Pty Ltd
Contact Matthias Schurhoff, MD
Phone +13054919070
Email mschurhoff@oligomedic.com
Status Recruiting
Phase N/A
Start date September 22, 2021
Completion date December 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03588975 - A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee Phase 3
Completed NCT01076673 - Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration Phase 2
Terminated NCT03678948 - Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions N/A
Terminated NCT05082831 - Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage Phase 1
Withdrawn NCT05300490 - Prednisolone Urinary Excretion Kinetics
Recruiting NCT05924763 - The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions N/A
Completed NCT02118519 - Mesenchymal Stem Cells in Knee Cartilage Injuries Phase 2
Active, not recruiting NCT02524509 - the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee Phase 4
Completed NCT01576159 - Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises Phase 0
Completed NCT03101163 - Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee Phase 2