Post-Operative Thoracolumosacral Orthosis for PJK

Phase 4RecruitingNCT06491030

Hospital for Special Surgery, New York84 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Proximal Junctional Kyphosis Adult Spinal Deformity Surgery Thoracolumbosacral Orthosis

Interventions

Align PJK™ TLSO braceDEVICE

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

Standard of CareOTHER

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (6)

Indiana Spine Group

Carmel, Indiana, United States

ACTIVE_NOT_RECRUITING

University of Kansas

Overland Park, Kansas, United States

ACTIVE_NOT_RECRUITING

Hospital for Special Surgery

New York, New York, United States

RECRUITING

University of Texas Health, Houston

Bellaire, Texas, United States

ACTIVE_NOT_RECRUITING

Texas Back Institute

Dallas, Texas, United States

ACTIVE_NOT_RECRUITING

Virgina Mason Franciscan Health

Seattle, Washington, United States

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

The incidence of proximal junctional kyphosis development

As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.

Time frame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.

Secondary Outcomes

Change in patient reported outcome measures

VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain

Time frame: 6 week and 6-month time points

Change in patient reported outcome measures

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)

Time frame: 6 week and 6-month time points