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Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures

RecruitingNAAges 58 Years - 84 YearsAllJiawei Jiang
NCT05519332 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * bone mineral density T scores \<-2.5; * compression of the vertebral anterior column greater than two-thirds of their original height; * Kyphosis with LKA greater than 20°; * the accordion phenomenon: the different angles of a supine CT scan and a lateral standing X-ray measurement; * upper or lower vertebral endplate fracture; * the involved vertebral body was intact; * Elderly patients with a history of major illness (such as cardiovascular disease, cancer or active malignancy) and were intolerant of the traditional open surgery. Exclusion Criteria: * Pathological vertebral fractures caused by spinal tumors, spinal tuberculosis, and spinal infection and so on; * Patients with symptoms of nerve roots or spinal cord compression; * Patients with a previous history of spinal fusion; * A history of abnormal bleeding or coagulation disorder dysfunction.
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What it tests

  • percutaneous vertebral-disc plasty
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Where

1 site
Affiliated 2 Hospital of Nantong University
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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