Post-Operative Thoracolumosacral Orthosis for PJK
Start Date
12/2/2024
Completion Date
12/1/2026
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
Age Range: 30 years to 75 years
Interventions
Align PJK™ TLSO brace
Standard of Care
Conditions
Locations
Indiana Spine Group
Carmel, Indiana 46032
United States
University of Kansas
Overland Park, Kansas 66211
United States
Hospital for Special Surgery
New York, New York 10021
United States
University of Texas Health, Houston
Bellaire, Texas 77401
United States
Texas Back Institute
Dallas, Texas 75243
United States
Virgina Mason Franciscan Health
Seattle, Washington 98101
United States