NCT01833962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

April 12, 2013

Last Update Submit

April 20, 2015

Conditions

Lumbar Fusion

Keywords

Lumbar fusion ratesActifuse synthetic bone graftBaxter HealthcareOther synthetic bone graft

Outcome Measures

Primary Outcomes (1)

  • Achievement of fusion prior to or at 12 months postoperatively

    6 - 12 months year

Study Arms (1)

Actifuse

Patients who recieved Actifuse synthetic bone brafting material

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoGeorgia

Macon, Georgia, 31210, United States

Location

Related Links

Study Officials

  • William B Dasher, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 17, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

US(1)