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

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ClinicalTrials.gov Identifier: NCT01833962
Recruitment Status : Unknown
Verified April 2015 by OrthoGeorgia.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Lumbar Fusion

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : January 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Actifuse
Patients who recieved Actifuse synthetic bone brafting material


Outcome Measures

Primary Outcome Measures :
  1. Achievement of fusion prior to or at 12 months postoperatively [ Time Frame: 6 - 12 months year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833962


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

Additional Information:
Responsible Party: OrthoGeorgia
ClinicalTrials.gov Identifier: NCT01833962     History of Changes
Other Study ID Numbers: 001-3708
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

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