Postoperative Bracing for Spinal Deformity Clinical Trial
Official title:
Utility of Postoperative Bracing: A Single-institution, Randomized-control Trial Comparing Brace to No-brace for Patients Undergoing Long-segment Fusion for Spinal Deformity
| Verified date | October 2021 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | December 30, 2021 |
| Est. primary completion date | December 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 |