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Post-Operative Thoracolumosacral Orthosis for PJK

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Dec 2, 2024
    • Site details revised at 6 of 6 sites
    v3
  3. Start date: Aug 2024 to Sep 2024v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06491030
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Aspen Medical Products
Conditions
(from sponsor)		 Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery, Thoracolumbosacral Orthosis
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov