Back to Trials
NCT06491030PHASE4Recruiting

Post-Operative Thoracolumosacral Orthosis for PJK

Hospital for Special Surgery, New York

Start Date

12/2/2024

Completion Date

12/1/2026

Summary

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.

Eligibility Criteria

Age Range: 30 years to 75 years

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

Interventions

DEVICE

Align PJK™ TLSO brace

OTHER

Standard of Care

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Proximal Junctional KyphosisAdult Spinal Deformity SurgeryThoracolumbosacral Orthosis

Locations

Indiana Spine Group

Carmel, Indiana 46032

United States

University of Kansas

Overland Park, Kansas 66211

United States

Hospital for Special Surgery

New York, 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