A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Baxter Healthcare Corporation14 sites in 3 countries329 target enrollmentSeptember 2009

ConditionsDegenerative Disc Disease Herniated Disc Spinal Stenosis Spondylolithesis Spinal Deformity Cervical Myelopathy Failed Back Surgery Syndrome Spinal Cord Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Baxter Healthcare Corporation
Enrollment: 329
Locations: 14
Primary Endpoint: Evidence of successful radiographic fusion
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

November 2013

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
•The patient is ≥18 years old and of legal age of consent.
•The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
•The patient is skeletally mature (epiphyses closed).
•The patient has signed the IRB approved informed consent.
•The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria

•Patient has systemic infection or infection at the surgical site.
•Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
•Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
•Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
•The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
•Patient is participating in another investigational study, which could confound results.

Outcomes

Primary Outcomes

Evidence of successful radiographic fusion

Time Frame: 6 months, 12 months & 24 months

Secondary Outcomes

Improvement of pain/function in comparison to pre-operative QOL scores(6 months, 12 months & 24 months)
Maintenance or improvement in neurological status, as compared to baseline scores(6 months 12 months & 24 months)