CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

Completed

• Conditions: Spinal Fusions

• Registration Number: NCT00768924
• Lead Sponsor: Zimmer Biomet

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2007-12
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-08
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

South Texas Spine Clinic; 🇺🇸 San Antonio, Texas, United States