Post-Operative Thoracolumosacral Orthosis for PJK

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. 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

Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery, Thoracolumbosacral Orthosis

Study Overview

Study Details

Study overview

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.

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

Post-Operative Thoracolumosacral Orthosis for PJK

Condition
Proximal Junctional Kyphosis
Intervention / Treatment

-

Contacts and Locations

Carmel

Indiana Spine Group, Carmel, Indiana, United States, 46032

Overland Park

University of Kansas, Overland Park, Kansas, United States, 66211

New York City

Hospital for Special Surgery, New York City, New York, United States, 10021

Bellaire

University of Texas Health, Houston, Bellaire, Texas, United States, 77401

Dallas

Texas Back Institute, Dallas, Texas, United States, 75243

Seattle

Virgina Mason Franciscan Health, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

30 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hospital for Special Surgery, New York,

Study Record Dates

2026-12