NCT06491030 · Hospital for Special Surgery, New York
Post-Operative Thoracolumosacral Orthosis for PJK
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Align PJK™ TLSO brace
Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
OTHER
Standard of Care
Patients will receive the standard of care postoperative instructions without a brace
Primary outcome measures
The incidence of proximal junctional kyphosis development
Time frame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Carmel, Indiana
- Overland Park, Kansas
- New York, New York
- Bellaire, Texas
- Dallas, Texas
- Seattle, Washington
Collaborators
Aspen Medical Products
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations