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Post-Operative Thoracolumosacral Orthosis for PJK

RecruitingPhase 4Ages 30 Years - 75 YearsAllHospital for Special Surgery, New York
NCT06491030 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Align PJK™ TLSO brace
  • Standard of Care
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Where

6 sites
Indiana Spine Group
Carmel, United States
University of Kansas
Overland Park, United States
Hospital for Special Surgery
New York, United States
University of Texas Health, Houston
Bellaire, United States
Texas Back Institute
Dallas, United States
Virgina Mason Franciscan Health
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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