RECRUITING

Post-Operative Thoracolumosacral Orthosis for PJK

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-02
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06491030

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.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 30-75-years-old
  2. * 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.
  1. * Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
  2. * Body mass index (BMI) \>35 kg/m2
  3. * Revision fusions
  4. * Fusions for trauma
  5. * Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
  6. * An underlying inflammatory arthropathy

Contacts and Locations

Study Locations (Sites)

Indiana Spine Group
Carmel, Indiana, 46032
United States
University of Kansas
Overland Park, Kansas, 66211
United States
Hospital for Special Surgery
New York City, New York, 10021
United States
University of Texas Health, Houston
Bellaire, Texas, 77401
United States
Texas Back Institute
Dallas, Texas, 75243
United States
Virgina Mason Franciscan Health
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-02
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-02
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Proximal Junctional Kyphosis
  • Adult Spinal Deformity Surgery
  • Thoracolumbosacral Orthosis