A Study to Evaluate the Safety of Augment™ Bone Graft
Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee|
- To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Collection of related adverse events
- To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Assess healing and bone formation from radiological reports
|Study Start Date:||July 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Single Arm.. Augment Bone Graft for Osteochondral Defects
Device: Augment Bone Graft
Augment Bone Graft physically fills bone defects by providing a biocompatible scaffold for new bone formation.The material is comprised of a matrix of beta tricalcium phosphate and a highly purified recombinant human platelet-derived growth factor.
Other Name: Bone Graft
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290991
|Canada, Nova Scotia|
|Queen Elizabeth ll Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||William D Stanish, MD||Capital Dictrict Health Authority|