CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest|
- Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Spinal fusion patients
Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.