Status:
RECRUITING
Post-Operative Thoracolumosacral Orthosis for PJK
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Aspen Medical Products
Conditions:
Proximal Junctional Kyphosis
Adult Spinal Deformity Surgery
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06491030
Start Date
December 2 2024
End Date
December 1 2026
Last Update
January 28 2025
Active Locations (6)
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1
Indiana Spine Group
Carmel, Indiana, United States, 46032
2
University of Kansas
Overland Park, Kansas, United States, 66211
3
Hospital for Special Surgery
New York, New York, United States, 10021
4
University of Texas Health, Houston
Bellaire, Texas, United States, 77401