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Post-Operative Thoracolumosacral Orthosis for PJK
Sponsor: Hospital for Special Surgery, New York
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.
Official title: The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2024-12-02
Completion Date
2026-12
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
Align PJK™ TLSO brace
Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
Standard of Care
Patients will receive the standard of care postoperative instructions without a brace
Locations (6)
Indiana Spine Group
Carmel, Indiana, United States
University of Kansas
Overland Park, Kansas, United States
Hospital for Special Surgery
New York, New York, United States
University of Texas Health, Houston
Bellaire, Texas, United States
Texas Back Institute
Dallas, Texas, United States
Virgina Mason Franciscan Health
Seattle, Washington, United States