Using a special brace to prevent complications after spinal surgery
The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
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 |
| Enrollment | 84 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 6 sites (Carmel, Indiana and 5 other locations) |
| Trial ID | NCT06491030 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-75 undergoing primary thoracolumbosacral fusion for adult spinal deformity.
Not a fit: Patients with osteoporosis, high BMI, or those requiring revision fusions or with neuromuscular conditions will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Carmel, Indiana and 5 other locations
- Indiana Spine Group — Carmel, Indiana, United States (Active_not_recruiting)
- University of Kansas — Overland Park, Kansas, United States (Active_not_recruiting)
- Hospital for Special Surgery — New York, New York, United States (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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.