NCT06491030 Post-Operative Thoracolumosacral Orthosis for PJK
| NCT ID | NCT06491030 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Proximal Junctional Kyphosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 84 participants in total. It began in 2024-12-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06491030 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Proximal Junctional Kyphosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06491030 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06491030 currently recruiting?
Yes, NCT06491030 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital for Special Surgery, New York to inquire about joining.
Where is the NCT06491030 trial being conducted?
This trial is being conducted at Carmel, United States, Overland Park, United States, New York, United States, Bellaire, United States and 2 additional locations.
Who is sponsoring the NCT06491030 clinical trial?
NCT06491030 is sponsored by Hospital for Special Surgery, New York. The trial plans to enroll 84 participants.