Overview

This trial is active, not recruiting.

Condition lumbar fusion
Sponsor OrthoGeorgia
Collaborator Baxter Healthcare Corporation
Start date January 2013
End date August 2015
Trial size 100 participants
Trial identifier NCT01833962, 001-3708

Summary

The purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients who recieved Actifuse synthetic bone brafting material

Primary Outcomes

Measure
Achievement of fusion prior to or at 12 months postoperatively
time frame: 6 - 12 months year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Any patient 18 years of age or older - Patients with a minimum follow up of 1 year - Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures Exclusion Criteria: - Patients under the age of 18 - Any patient with less than 1 year of follow up history at the time of first data analysis - Any patient that the primary investigator deems as an unfit candidate

Additional Information

Official title A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
Principal investigator William B Dasher, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by OrthoGeorgia.