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Post-Operative Thoracolumosacral Orthosis for PJK
NCT06491030 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06491030 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Indiana, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06491030?
The interventions under investigation include: Align PJK™ TLSO brace (DEVICE), Standard of Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06491030?
This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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