Spinal Fusions
Conditions
Keywords
Bone Void Filler, Post-Harvest Iliac Crest, Ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed