Actively Recruiting
Post-Operative Thoracolumosacral Orthosis for PJK
Led by Hospital for Special Surgery, New York · Updated on 2026-02-13
84
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
A
Aspen Medical Products
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Operative Thoracolumosacral Orthosis for PJK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 30 and 75 years
- Undergoing primary thoracolumbosacral fusion for adult spinal deformity with an upper instrumented vertebra between T8 and L2 and a lower instrumented vertebra of S1 or the ilium
You will not qualify if you...
- Osteoporosis with a T-score less than -2.5 at the time of surgery
- Body mass index greater than 35 kg/m2
- Previous revision spinal fusion surgeries
- Spinal fusions performed for trauma
- Neuromuscular causes of spinal deformity such as Parkinson's disease, cerebral palsy, or post-stroke
- Having an underlying inflammatory arthropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Indiana Spine Group
Carmel, Indiana, United States, 46032
Active, Not Recruiting
2
University of Kansas
Overland Park, Kansas, United States, 66211
Active, Not Recruiting
3
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
4
University of Texas Health, Houston
Bellaire, Texas, United States, 77401
Active, Not Recruiting
5
Texas Back Institute
Dallas, Texas, United States, 75243
Active, Not Recruiting
6
Virgina Mason Franciscan Health
Seattle, Washington, United States, 98101
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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