Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compressi… (NCT05519332) | Clinical Trial Compass
RecruitingNot Applicable
Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
China100 participantsStarted 2020-03-01
Plain-language 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.
Who can participate
Age range
58 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline visual analogue scale
Timeframe: One day before operation, one day after operation and 1year.
2
Change from Baseline Oswestry Disability Index
Timeframe: One day before operation, one day after operation and 1year.
3
Change from Baseline the local kyphotic angle
Timeframe: One day before operation, one day after operation and 1year.