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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fusions

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Spinal fusion patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): September 30, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: 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.
• Other Study ID Numbers: 2006-012