CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
Completed
Conditions studied: Spinal Fusions
In brief
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.
Key facts
- Study ID
- NCT00768924
- Run by
- Zimmer Biomet
- People needed
- 35
- Starts
- 2007-03-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2011-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- South Texas Spine Clinic — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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