Postoperative Bracing for Spinal DeformityNCT03947541
Utility of Postoperative Bracing
A study testing Thoracolumbosacral (TLSO) brace and No Bracing in people with Postoperative Bracing for Spinal Deformity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Bracing for Spinal Deformity
- What is being tested?
- Thoracolumbosacral (TLSO) brace and No Bracing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
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.
- Being tested
- Thoracolumbosacral (TLSO) brace, No Bracing
- Keywords
- Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbosacral (TLSO) braceOther
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 BracingOther
Participants will not wear a brace in the study.
| Study group | Role | What they receive |
|---|---|---|
| No Brace | Active comparator | Patients randomized to the no-brace group will not be required to wear a brace, postoperatively. Receives: Other: No Bracing |
| 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. Receives: Other: Thoracolumbosacral (TLSO) brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Change in Visual Analogue Scale (VAS)
Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start14 May 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Bracing for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Karikari, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947541
- Sponsor's protocol ID
- Pro00100497
- Status last verified
- Oct 2021
- First submitted
- 9 May 2019
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03947541
- Acronym / sponsor ID
- Pro00100497
- Keywords
- Thoracolumbosacral (TLSO) brace, Lumbosacral orthotic (LSO) brace, Adult spinal deformity, Postoperative Brace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Brace | Active comparator | Other: No BracingPatients randomized to the no-brace group will not be required to wear a brace, postoperatively. |
| Brace | Experimental | Other: Thoracolumbosacral (TLSO) bracePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbosacral (TLSO) bracePatients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period. | Other | Brace |
| No BracingParticipants will not wear a brace in the study. | Other | No Brace |
Primary outcome
Change in Oswestry Disability Index (ODI) score
Time frame: 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.
2 secondary outcomes
Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Change in Visual Analogue Scale (VAS)
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Karikari, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbosacral (TLSO) brace and No Bracing in people with Postoperative Bracing for Spinal Deformity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) score (time frame: Baseline, 3 months, 6 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.