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

Sponsored by:	Zimmer, Inc.
Information provided by:	Zimmer, Inc.
ClinicalTrials.gov Identifier:	NCT00768924

Purpose

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
Spinal Fusions

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:

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. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	March 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Spinal fusion patients

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768924

Locations

United States, Texas
South Texas Spine Clinic
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Zimmer, Inc.

More Information

No publications provided

Responsible Party:	Zimmer Spine ( Kristin Jans, Associate Director, Regulatory Affairs )
Study ID Numbers:	2006-012
Study First Received:	October 3, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00768924 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:

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.

ClinicalTrials.gov processed this record on May 07, 2009