Utility of Postoperative Bracing

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Bracing for Spinal Deformity

Intervention / Treatment
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* Other: Thoracolumbosacral (TLSO) brace
* Other: No Bracing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Brace<br>Patients randomized to the no-brace group will not be required to wear a brace, postoperatively. | Other: No Bracing<br>* Participants will not wear a brace in the study.<br>|
| Experimental: Brace<br>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<br>* Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace