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NCT06491030 · ClinicalTrials.gov registry record · Phase 4
Post-Operative Thoracolumosacral Orthosis for PJK
A Phase 4 study of Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
- 6
- Study locations
NCT06491030: Recruiting Phase 4 study of Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery, sponsored by Hospital for Special Surgery, New York.
NCT06491030 is a Phase 4 study of Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 84 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06491030, a Phase 4 study of Proximal Junctional Kyphosis and Adult Spinal Deformity Surgery, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.
Conditions Studied
Interventions
- DEVICE Align PJK™ TLSO brace
- OTHER Standard of Care
Study Locations (6)
Texas
- University of Texas Health, Houston - Bellaire
- Texas Back Institute - Dallas
Indiana
- Indiana Spine Group - Carmel
Kansas
- University of Kansas - Overland Park
New York
- Hospital for Special Surgery - New York
Washington
- Virgina Mason Franciscan Health - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-12-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT06491030 shows while recruiting
NCT06491030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Proximal Junctional Kyphosis appearing as the primary indexed condition, and to 2 interventions - of which Align PJK™ TLSO brace is the first listed.
NCT06491030 lists 6 locations in 5 states (Texas, Indiana, Kansas).
Frequently Asked Questions
What is clinical trial NCT06491030 about?
NCT06491030 is a clinical study titled "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...
What is the current status of trial NCT06491030?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2024-12-02. Estimated completion is 2026-12.
What conditions does trial NCT06491030 study?
This clinical trial studies the following conditions: Proximal Junctional Kyphosis, Adult Spinal Deformity Surgery, Thoracolumbosacral Orthosis.
What interventions are being tested in trial NCT06491030?
The interventions under investigation include: Align PJK™ TLSO brace (DEVICE), Standard of Care (OTHER).
Who is sponsoring clinical trial NCT06491030?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06491030 being conducted?
This trial has 6 study locations across Indiana, Kansas, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06491030's enrollment target sits among peer trials
84 929th of 2000 higher than 1,065 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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