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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Spinal fusion patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Spine Clinic | San Antonio | Texas | 78229 | United States |
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