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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Fusions

Keywords

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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.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Spinal fusion patients

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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South Texas Spine Clinic

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2006-012

Identifier Type: -

Identifier Source: org_study_id