NCT05519332 Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
| NCT ID | NCT05519332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiawei Jiang |
| Condition | Osteoporotic Fracture of Vertebra |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2025-07 |
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.
This trial targets 100 participants in total. It began in 2020-03-01 with a primary completion date of 2025-07.
⚠ 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
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.
Eligibility Criteria
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.
Contact & Investigator
Guanhua Xu, Dr
PRINCIPAL INVESTIGATOR
Affiliated 2 Hospital of Nantong University
Frequently Asked Questions
Who can join the NCT05519332 clinical trial?
This trial is open to participants of all sexes, aged 58 Years or older, up to 84 Years, studying Osteoporotic Fracture of Vertebra. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05519332 currently recruiting?
Yes, NCT05519332 is actively recruiting participants. Contact the research team at 18862802782@163.com for enrollment information.
Where is the NCT05519332 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT05519332 clinical trial?
NCT05519332 is sponsored by Jiawei Jiang. The principal investigator is Guanhua Xu, Dr at Affiliated 2 Hospital of Nantong University. The trial plans to enroll 100 participants.