Utility of Postoperative Bracing

Not Applicable

Completed

• Conditions: Postoperative Bracing for Spinal Deformity
• Interventions: Other: No Bracing; Other: Thoracolumbosacral (TLSO) brace

• Registration Number: NCT03947541
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Study Start: 2019-05-14
• Status Verified: 2021-10
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Brace	No Bracing	Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.
Brace	Thoracolumbosacral (TLSO) 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.

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI) score	Baseline, 3 months, 6 months, 12 months and 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)	Baseline, 3 months, 6 months, 12 months and 24 months	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.
Change in Visual Analogue Scale (VAS)	Baseline, 3 months, 6 months, 12 months and 24 months	Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States