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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01833962
Other study ID # 001-3708
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT06066879 - Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery Phase 4
Recruiting NCT05583864 - Lumbar Fusion With Porous Versus Non-Porous Cages N/A
Completed NCT00620399 - A Study on the Use of a Brace Following Low Back Surgery Phase 3
Terminated NCT01703338 - Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery
Not yet recruiting NCT01269398 - GO-LIF With Percutaneous Facet Fusion N/A

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