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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 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. The trial reports 6 study locations across 5 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06491030
The ClinicalTrials.gov registry entry for NCT06491030 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.
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