Minimally invasive treatment for severe osteoporotic vertebral fractures
Official title: Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
Run by Affiliated 2 Hospital of Nantong University · NCT05519332 · Data updated 2026-11-12
This study is testing two different minimally invasive procedures to see which one helps older adults with severe osteoporosis-related spine fractures feel better and have a more stable back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 58 Years to 84 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Affiliated 2 Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Status | Recruiting |
| Started | March 1, 2020 |
| Main results expected | July 2025 |
| Study ends | December 2025 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT05519332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are elderly patients with very severe osteoporotic vertebral compression fractures who are not suitable for traditional open surgery.
✕Probably not a fit
Patients with pathological fractures due to tumors or infections, or those with significant nerve compression symptoms, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the outcomes of two minimally invasive procedures for treating very severe osteoporotic vertebral compression fractures in elderly patients. Participants are randomly assigned to either percutaneous vertebroplasty (PVP) or percutaneous vertebral-disc plasty (PVDP), with both techniques involving the injection of bone cement to stabilize the vertebrae. The study evaluates clinical outcomes and radiological parameters, including pain levels and spinal alignment, before and after the procedures. The aim is to determine which method provides better relief from back pain and improves spinal stability.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for elderly patients suffering from severe osteoporotic fractures, enhancing their quality of life.
How similar studies have gone: Previous studies have shown promising results with similar minimally invasive techniques for treating osteoporotic fractures, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Affiliated 2 Hospital of Nantong University
Nantong, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Guanhua Xu, Dr — Affiliated 2 Hospital of Nantong University
- Study coordinator: Jiawei Jiang, Dr
- Email: 18862802782@163.com
- Phone: 18862802782
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
VCFix Spinal System in vertebral compression fractures due to osteoporosis
This study tests the VCFix Spinal System in real-world US patients with vertebral compression fractures from osteoporosis to see how it performs outside a controlled trial.
-
Assessing Osteosarcopenia in Patients with Hip Fractures
This study is testing if certain tests can help identify muscle and bone issues in patients with hip fractures to improve their recovery after surgery.
-
Post-osteoporotic fracture exercise program
Aimed at people with osteoporosis who recently had a fracture, the study tests group exercise classes to see if they are feasible and safe and could help bone health and physical function.
-
MDW blood test to predict complications and survival after hip fracture
This will test whether a routine blood measure called Monocyte Distribution Width (MDW) can help predict complications or death in people aged 65 and older who have a low-energy hip fracture.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.