Minimally invasive treatment for severe osteoporotic vertebral fractures

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 58 Years to 84 Years
• Sex: All
• Sponsor: Affiliated 2 Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT05519332 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are elderly patients with very severe osteoporotic vertebral compression fractures who are not suitable for traditional open surgery.

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.

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 performed: Previous studies have shown promising results with similar minimally invasive techniques for treating osteoporotic fractures, suggesting potential for success in this approach.

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.

Where this trial is running

Nantong, Jiangsu

• 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

Conditions Osteoporotic Fracture of Vertebra; percutaneous vertebroplasty; percutaneous cement discoplasty