NCT00620399

Brief Summary

This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 1996

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

7.1 years

First QC Date

February 11, 2008

Last Update Submit

April 16, 2020

Conditions

Lumbar Fusion

Keywords

lumbar fusion

Outcome Measures

Primary Outcomes (1)

  • functional outcome scores

    2 years following surgery

Study Arms (2)

1

EXPERIMENTAL

brace

Other: lumbar corset

2

PLACEBO COMPARATOR

no brace

Other: lumbar corset

Interventions

lumbar corsetOTHER
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Undergoing posterior lumbar fusion surgery for degenerative conditions

You may not qualify if:

  • Unable to complete questionnaires due to language or cognitive barrier
  • Declined study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

May 1, 1996

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

US(1)