Post-Operative Thoracolumosacral Orthosis for PJK

Last updated: January 24, 2025
Sponsor: Hospital for Special Surgery, New York
Overall Status: Active - Recruiting

Phase

4

Condition

Birth Defects

Holoprosencephaly

Treatment

Align PJK™ TLSO brace

Standard of Care

Clinical Study ID

NCT06491030
2023-2446
  • Ages 30-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 30-75-years-old

  • Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumentedvertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or theilium.

Exclusion

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

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Align PJK™ TLSO brace
Phase: 4
Study Start date:
December 02, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Indiana Spine Group

    Carmel, Indiana 46032
    United States

    Site Not Available

  • University of Kansas

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York City, New York 10021
    United States

    Active - Recruiting

  • University of Texas Health, Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Back Institute

    Dallas, Texas 75243
    United States

    Site Not Available

  • Virgina Mason Franciscan Health

    Seattle, Washington 98101
    United States

    Site Not Available

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