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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00768924
First received: October 3, 2008
Last updated: September 28, 2011
Last verified: February 2009
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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, Inc.
ClinicalTrials.gov Identifier: NCT00768924     History of Changes
Other Study ID Numbers: 2006-012
Study First Received: October 3, 2008
Last Updated: September 28, 2011
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 23, 2013