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

Lumbar Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01833962
• Other study ID #: 001-3708
• Status: Active, not recruiting
• Phase: N/A
• First received: April 12, 2013
• Last updated: April 20, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: OrthoGeorgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Baxter Healthcare: Deerfield, IL. United States
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lumbar Fusion

Locations

Country	Name	City	State
United States	OrthoGeorgia	Macon	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
OrthoGeorgia	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of fusion prior to or at 12 months postoperatively		6 - 12 months year	No

External Links

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