Back to resultsUtility of Postoperative Bracing
Primary Purpose
Postoperative Bracing for Spinal Deformity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracolumbosacral (TLSO) brace
No Bracing
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Bracing for Spinal Deformity focused on measuring Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
No Brace
Brace
Arm Description
Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in Visual Analogue Scale (VAS)
Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03947541
Brief Title
Utility of Postoperative Bracing
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Bracing for Spinal Deformity
Keywords
Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Brace
Arm Type
Active Comparator
Arm Description
Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.
Arm Title
Brace
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Thoracolumbosacral (TLSO) brace
Intervention Description
Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.
Intervention Type
Other
Intervention Name(s)
No Bracing
Intervention Description
Participants will not wear a brace in the study.
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI) score
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months and 24 months
Title
Change in Visual Analogue Scale (VAS)
Description
Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.
Time Frame
Baseline, 3 months, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Karikari, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utility of Postoperative Bracing
We'll reach out to this number within 24 hrs