CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is 18 years and older
- •Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
- •Patient must be skeletally mature.
- •Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.
Exclusion Criteria
- •Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
- •Patient is pregnant.
- •Patient has a severe degenerative bone disease.
- •Patient has systemic conditions which would affect bone or wound healing.
- •Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
- •Patient is suffering from mental illness, alcohol abuse or drug abuse.
- •Patient has known allergies to bovine collagen.
- •Patient has a history of multiple allergies.
- •Patient has infection at the surgical site.
- •Significantly impaired vascularity proximal to surgical site.
- •Sites are in direct contact with articular space.
- •Sites where stresses on void will exceed the load strength of fixation hardware.
- •Patient has hypercalcemia.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported