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Post-Operative Thoracolumosacral Orthosis for PJK

The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery

Who can join

Ages 30 to 75 · All sexes

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

About the study

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.

What is being tested

• Align PJK™ TLSO brace (device)
• Standard of Care (other)

Sponsor: Hospital for Special Surgery, New York · Participants: 84 · Started: Dec 2, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06491030

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.