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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 58
Maximum Age: 84
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Affiliated 2 Hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
Jiawei Jiang, Dr
18862802782@163.com
18862802782
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: PVDP group
Patients underwent percutaneous vertebral-disc plasty
No_intervention: PVP group
Patients underwent conventional percutaneous vertebroplasty
Related Therapeutic Areas
Sponsors
Leads: Jiawei Jiang

This content was sourced from clinicaltrials.gov