Using a special brace to prevent complications after spinal surgery
Official title: The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
Run by Hospital for Special Surgery, New York · NCT06491030 · Data updated 2026-11-12
This study is testing if a special brace can help prevent complications after spinal surgery for adults with spinal deformities.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 6 sites (Carmel, Indiana and 5 other locations) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06491030 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 30-75 undergoing primary thoracolumbosacral fusion for adult spinal deformity.
✕Probably not a fit
Patients with osteoporosis, high BMI, or those requiring revision fusions or with neuromuscular conditions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of a novel thoracolumbosacral orthosis (TLSO) brace in preventing proximal junctional kyphosis (PJK) in patients undergoing thoracolumbosacral fusion for adult spinal deformity. The study involves 84 patients and compares the outcomes of those using the TLSO brace against standard post-operative care. The primary outcome measure is the change in the proximal junctional angle as seen on X-rays taken six months after surgery. The trial aims to provide insights into whether this intervention can reduce the incidence of symptomatic PJK, which may require further surgical intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of complications following spinal surgery, leading to better patient outcomes.
How similar studies have gone: While the efficacy of post-operative bracing in preventing PJK is not well-established, this study aims to explore a novel approach in a multi-center setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 30-75-years-old * Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium. Exclusion Criteria: * Osteoporosis (defined as a T-score \<-2.5 at the time of surgery) * Body mass index (BMI) \>35 kg/m2 * Revision fusions * Fusions for trauma * Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.) * An underlying inflammatory arthropathy
Where it's running
-
Hospital for Special Surgery
New York, New York, United States Recruiting -
Indiana Spine Group
Carmel, Indiana, United States Active not recruiting -
University of Kansas
Overland Park, Kansas, United States Active not recruiting -
University of Texas Health, Houston
Bellaire, Texas, United States Active not recruiting -
Texas Back Institute
Dallas, Texas, United States Active not recruiting -
Virgina Mason Franciscan Health
Seattle, Washington, United States Active not recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.