Lumbar Fusion Clinical Trial
Official title:
A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
Verified date | April 2015 |
Source | OrthoGeorgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Baxter Healthcare: Deerfield, IL. United States |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | OrthoGeorgia | Macon | Georgia |
Lead Sponsor | Collaborator |
---|---|
OrthoGeorgia | Baxter Healthcare Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achievement of fusion prior to or at 12 months postoperatively | 6 - 12 months year | No |
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