Post-Operative Thoracolumosacral Orthosis for PJK

Phase 4

Recruiting

• Conditions: Adult Spinal Deformity Surgery; Proximal Junctional Kyphosis; Thoracolumbosacral Orthosis

• Registration Number: NCT06491030
• Lead Sponsor: Hospital for Special Surgery, New York

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-08
• Study Start: 2024-12-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of proximal junctional kyphosis development	This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.	As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.

Secondary Outcome Measures

Name	Time	Method
Change in patient reported outcome measures	6 week and 6-month time points	Oswestry Disability Index (0-20% minimal disability; 21-40% moderate disability; 41-60% severe disability; 61-80 cripple, pain impinges on all aspects of life; 81-100% patients are bed bound)

Trial Locations

Locations (6)

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

University of Kansas; 🇺🇸 Overland Park, Kansas, United States

Hospital for Special Surgery; 🇺🇸 New York City, 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