Post-Operative Thoracolumosacral Orthosis for PJK
The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
Hospital for Special Surgery, New York
84 participants
Dec 2, 2024
INTERVENTIONAL
Conditions
Summary
Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.
Eligibility
Inclusion Criteria2
- 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 Criteria6
- 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
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Interventions
Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
Patients will receive the standard of care postoperative instructions without a brace
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06491030