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NCT Number: NCT06491030

Post-Operative Thoracolumosacral Orthosis for PJK

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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Key information

Conditions

Proximal Junctional Kyphosis Adult Spinal Deformity Surgery Thoracolumbosacral Orthosis

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana Spine Group, Carmel, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Align PJK™ TLSO brace

Device

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

Standard of care

Other

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

Primary outcomes

  1. The incidence of proximal junctional kyphosis development

    Time frame: 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 outcomes

  1. Change in patient reported outcome measures

    Time frame: 6 week and 6-month time points

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

  2. Change in patient reported outcome measures

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Aspen Medical Products

Registry information

Official study title

The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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