Post-Operative Thoracolumosacral Orthosis for PJK
Trial Parameters
Brief 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 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