Status:
COMPLETED
CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
Lead Sponsor:
Zimmer Biomet
Conditions:
Spinal Fusions
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00768924
Start Date
March 1 2007
End Date
December 1 2008
Last Update
September 30 2011
Active Locations (1)
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1
South Texas Spine Clinic
San Antonio, Texas, United States, 78229