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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by OrthoGeorgia
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
OrthoGeorgia
ClinicalTrials.gov Identifier:
NCT01833962
First received: April 12, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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.


Condition
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: November 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Actifuse
Patients who recieved Actifuse synthetic bone brafting material

  Eligibility

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

Criteria

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

Contacts
Contact: Craig C Odum 478-254-5377 codum@orthoga.org

Locations
United States, Georgia
OrthoGeorgia Recruiting
Macon, Georgia, United States, 31210
Contact: Craig C Odum    478-254-5377    codum@orthoga.org   
Sponsors and Collaborators
OrthoGeorgia
Baxter Healthcare Corporation
Investigators
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: October 14, 2014
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 October 20, 2014