RecruitingPhase 4NCT06491030

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


Sponsor

Hospital for Special Surgery, New York

Enrollment

84 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Align PJK™ TLSO brace and Standard of Care for people with adult spinal deformity surgery, proximal junctional kyphosis, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 30 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlign PJK™ TLSO brace

Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.

OTHERStandard of Care

Patients will receive the standard of care postoperative instructions without a brace


Locations(6)

Indiana Spine Group

Carmel, Indiana, United States

University of Kansas

Overland Park, Kansas, United States

Hospital for Special Surgery

New York, New York, United States

University of Texas Health, Houston

Bellaire, Texas, United States

Texas Back Institute

Dallas, Texas, United States

Virgina Mason Franciscan Health

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06491030