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Post-Operative Thoracolumosacral Orthosis for PJK

NCT06491030 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Proximal Junctional Kyphosis
  • Adult Spinal Deformity Surgery
  • Thoracolumbosacral Orthosis

Interventions

DEVICE

Align PJK™ TLSO brace

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

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Aspen Medical Products

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06491030 on ClinicalTrials.gov