A Study on the Use of a Brace Following Low Back Surgery

Lumbar Fusion Clinical Trial

Official title:

Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620399
• Other study ID #: 019511
• Status: Completed
• Phase: Phase 3
• Start date: May 1996
• Est. completion date: June 2003

Study information

• Verified date: April 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80

• Undergoing posterior lumbar fusion surgery for degenerative conditions

Exclusion Criteria:

• Unable to complete questionnaires due to language or cognitive barrier

• Declined study participation

Related Conditions & MeSH terms

• Lumbar Fusion

Intervention

Other:
• lumbar corset

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Medtronic Sofamor Danek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome scores		2 years following surgery