CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
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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.
Condition or disease
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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.
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.
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.