Utility of Postoperative Bracing

Utility of Postoperative Bracing: A Single-institution, Randomized-control Trial Comparing Brace to No-brace for Patients Undergoing Long-segment Fusion for Spinal Deformity

The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.

If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.

Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.

Study Overview

• Status: Completed
• Conditions: Postoperative Bracing for Spinal Deformity
• Intervention / Treatment: Other: No Bracing; Other: Thoracolumbosacral (TLSO) brace

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The principal investigator's new or returning patients
• Adults 18 to 80 years of old
• Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity

Exclusion Criteria:

• Patients who are undergoing a spinal fusion for other reasons besides deformity
• Patients who are unable to provide consent or fill out survey questionnaires
• Patients who have brace-prohibitive body habitus
• Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Brace; Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.	Other: No Bracing; Participants will not wear a brace in the study.
Experimental: Brace; Patients randomized to the brace group will wear the brace when out of bed and will be allowed to remove the brace when in bed. This intervention will continue through their 6-week postoperative visit, after which point, patients will be allowed to wear the brace for comfort.	Other: Thoracolumbosacral (TLSO) brace; Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oswestry Disability Index (ODI) score	Scores from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability.	Baseline, 3 months, 6 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)	Measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life.	Baseline, 3 months, 6 months, 12 months and 24 months
Change in Visual Analogue Scale (VAS)	Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.	Baseline, 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Thoracolumbosacral (TLSO) brace; Lumbosacral orthotic (LSO) brace; Adult spinal deformity; Postoperative Brace
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Pro00100497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No