Post-Operative Thoracolumosacral Orthosis for PJK

Recruiting now · Phase 4

Conditions studied: Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery, Thoracolumbosacral Orthosis

In brief

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.

Key facts

Study ID

NCT06491030

Run by

Hospital for Special Surgery, New York

People needed

84

Starts

2024-12-02

Expected to finish

2026-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States (enrolling)
• Indiana Spine Group — Carmel, Indiana, United States
• University of Kansas — Overland Park, Kansas, 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

Full record on ClinicalTrials.gov

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