Actively Recruiting
Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
Led by Jiawei Jiang · Updated on 2025-04-04
100
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs). This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.
CONDITIONS
Official Title
Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bone mineral density T scores <-2.5
- Compression of the vertebral anterior column greater than two-thirds of their original height
- Kyphosis with local kyphotic angle greater than 20°
- Accordion phenomenon shown by different angles on a supine CT scan and lateral standing X-ray
- Fracture of upper or lower vertebral endplate
- Intact involved vertebral body
- Elderly patients with major illness history (such as cardiovascular disease, cancer, or active malignancy) who cannot tolerate traditional open surgery
You will not qualify if you...
- Pathological vertebral fractures caused by spinal tumors, spinal tuberculosis, spinal infection, or similar conditions
- Symptoms of nerve root or spinal cord compression
- Previous history of spinal fusion
- History of abnormal bleeding or coagulation disorder dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated 2 Hospital of Nantong University
Nantong, Jiangsu, China, 0513
Actively Recruiting
Research Team
J
Jiawei Jiang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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