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New treatment option for Osteoporotic Fracture of Vertebra
Official title Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
ClinicalTrials.gov ID: NCT05519332
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 58 to 84
You may be able to join if
- 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;
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 58 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.