Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2019-05-14
2021-12-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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No Brace
Patients randomized to the no-brace group will not be required to wear a brace, postoperatively.
No Bracing
Participants will not wear a brace in the study.
Brace
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.
Thoracolumbosacral (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.
Interventions
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Thoracolumbosacral (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.
No Bracing
Participants will not wear a brace in the study.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Isaac Karikari, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00100497
Identifier Type: -
Identifier Source: org_study_id
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