A Study to Evaluate the Safety of Augment™ Bone Graft

Status Completed

Clinical Trial Summary

Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?

Clinical Trial Description

Subjects will be 18 to 40 years with an osteochondral defects of the knee.They will be candidates for allograft and Augment Bone Graft will be added to the procedure. The safety of Augment Bone Graft plus allograft for osteochondral defects of the knee will be evaluated by type, frequency, severity and relatedness of adverse events to the device for a minimum of 24 weeks.Magnetic Resonance Imaging will be performed at 1,12 and 42 weeks to evaluate device integrity and surgical treatment of osteochondral defects. Computed tomography will be done at week 1 and week 24 to determine the healing status of the osteochondral defect. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01290991
Study type	Interventional
Source	Nova Scotia Health Authority
Contact
Status	Completed
Phase	N/A
Start date	July 2011
Completion date	August 2012

View Details

See also
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
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
Terminated	`NCT01410136` - Chondrofix Osteochondral Allograft Prospective Study	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