Post-Operative Thoracolumosacral Orthosis for PJK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Proximal Junctional Kyphosis Adult Spinal Deformity Surgery Thoracolumbosacral Orthosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Thoracolumosacral Orthosis

Patients randomized to this arm will be fitted with an Aspen Medical Products "Align PJK™" TLSO brace. This is a 3-point, rigid hyperextension TLSO brace which is currently FDA approved under a 510k exemption but not commercially available. With this brace, the sternal pad height/width and belt component will be adjusted to optimize patient position and comfort. The brace will also be fitted with an external temperature sensing probe. Patients will be instructed to wear the brace at all times, including when in bed for 6-weeks post-operatively. At the 6-week visit patients will be asked to self-report compliance with the brace

Group Type EXPERIMENTAL

Align PJK™ TLSO brace

Intervention Type DEVICE

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

No brace

Patients in the control arm will be treated without a brace but will have no other differences in their post-operative treatment protocol. This will be considered "usual care" for the purposes of this study.

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Interventions

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Align PJK™ TLSO brace

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

Intervention Type DEVICE

Standard of Care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No