Postoperative Bracing for Spinal Deformity
Conditions
Keywords
Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace
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.
Interventions
OTHERThoracolumbosacral (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.
OTHERNo Bracing
Participants will not wear a brace in the study.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed