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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Brace | Active Comparator | Patients randomized to the no-brace group will not be required to wear a brace, postoperatively. |
|
| Brace | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracolumbosacral (TLSO) brace | Other | Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Karikari, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| No Bracing | Other | Participants will not wear a brace in the study. |
|
| 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 |