Defect of Articular Cartilage Clinical Trial
Official title:
A Post Market Study to Evaluate the Chondrofix® Osteochondral Allograft Utilized for Treatment of Subjects With Cartilage Lesions in the Knee
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Knee cartilage injuries are a major cause of pain and functional impairment in young to
middle age adults and can lead to progressive joint degeneration. In response to challenges
with current cartilage repair options, Chondrofix Allograft was developed as an
off-the-shelf treatment option adding to the variety of cartilage reparation offerings.
This study is a multicenter, prospective, post-market clinical outcomes study designed to
assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary
and revision cartilage repair cases. Study design includes up to 6 qualified investigational
sites with 50 subjects enrolled across all centers during an 18 month enrollment period.
Study subjects will be followed postoperatively for 5 years. The Investigators who are
responsible for the conduct of this study in compliance with this protocol will be
orthopedic surgeons who are skilled in the techniques of articular cartilage repair.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01473199 -
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
|
N/A | |
Active, not recruiting |
NCT01670617 -
DeNovo NT Natural Tissue Graft Stratified Knee Study
|
N/A | |
Active, not recruiting |
NCT01347892 -
DeNovo NT Ankle LDC Study
|
N/A | |
Completed |
NCT02203071 -
Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
|
||
Completed |
NCT01626677 -
Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
|
Phase 3 | |
Active, not recruiting |
NCT02855073 -
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
|
Phase 2 | |
Completed |
NCT01290991 -
A Study to Evaluate the Safety of Augmentâ„¢ Bone Graft
|
N/A | |
Terminated |
NCT01400607 -
Neocartilage Implant to Treat Cartilage Lesions of the Knee
|
Phase 3 | |
Terminated |
NCT00881023 -
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
|
N/A | |
Terminated |
NCT02542566 -
Protected Versus Early Weight Bearing Post Microfracture Surgery
|
N/A | |
Completed |
NCT02696876 -
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
|
N/A | |
Active, not recruiting |
NCT02524509 -
the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
|
Phase 4 | |
Active, not recruiting |
NCT02537067 -
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
|
Phase 3 | |
Recruiting |
NCT02519881 -
the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
|
Phase 4 | |
Active, not recruiting |
NCT02539030 -
Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
|
Phase 4 | |
Active, not recruiting |
NCT02659215 -
HyaloFAST Trial for Repair of Articular Cartilage in the Knee
|
N/A | |
Active, not recruiting |
NCT00885729 -
Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects
|
Phase 1 | |
Terminated |
NCT01246635 -
Smith & Nephew's European Trufit Study
|
N/A |