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Clinical Trials/NCT01833962
NCT01833962UnknownNot Applicable

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

OrthoGeorgia1 site in 1 country100 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Achievement of fusion prior to or at 12 months postoperatively
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Achievement of fusion prior to or at 12 months postoperatively

Time Frame: 6 - 12 months year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
OrthoGeorgia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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