A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

This study is ongoing, but not recruiting participants.
Baxter Healthcare Corporation
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 12, 2013
Last updated: April 20, 2015
Last verified: April 2015
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.

Lumbar Fusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

Resource links provided by NLM:

Further study details as provided by OrthoGeorgia:

Primary Outcome Measures:
  • Achievement of fusion prior to or at 12 months postoperatively [ Time Frame: 6 - 12 months year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Patients who recieved Actifuse synthetic bone brafting material


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All study patients will be extracted from our current patient population. A total of 50 patients treated with Actifuse and 50 patients treated with other synthetic bone grafting substitutes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833962

United States, Georgia
Macon, Georgia, United States, 31210
Sponsors and Collaborators
Baxter Healthcare Corporation
Principal Investigator: William B Dasher, MD Physician
  More Information

Additional Information:
No publications provided

Responsible Party: OrthoGeorgia
ClinicalTrials.gov Identifier: NCT01833962     History of Changes
Other Study ID Numbers: 001-3708 
Study First Received: April 12, 2013
Last Updated: April 20, 2015
Health Authority: Baxter Healthcare: Deerfield, IL. United States

Keywords provided by OrthoGeorgia:
Lumbar fusion rates
Actifuse synthetic bone graft
Baxter Healthcare
Other synthetic bone graft

ClinicalTrials.gov processed this record on February 08, 2016