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

NCT05519332 | Recruiting

• 1 other identifier: JJiang
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporotic Fracture of Vertebra

Keywords

percutaneous vertebroplasty; percutaneous cement discoplasty

Outcome Measures

Primary Outcomes (3)

• Change from Baseline visual analogue scale

  Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

  One day before operation, one day after operation and 1year.

• Change from Baseline Oswestry Disability Index

  The ODI assesses ten aspects of daily functions viz. pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. An ODI of 0-20% indicates minimal disability; the patients can cope with most living activities and usually no treatment is indicated, apart from advice on lifting, sitting and exercise. An ODI of 21-40% indicates moderate disability; the patients experience more pain and difficulty with sitting, lifting and standing; travel and social life are more difficult and they may be disabled from work; personal care, sexual activity and sleeping are not grossly affected. An ODI of 41-60% indicates severe disability; pain remains the main problem in this group of patients; the activities of daily living are affected. Patients with an ODI of 61-80% are severely crippled in function with back pain impinging on all aspects of the patient's life. Finally, an ODI of 81-100% indicates that the patients are bed-bound.

  One day before operation, one day after operation and 1year.

• Change from Baseline the local kyphotic angle

  The local kyphotic angle (LKA) was calculated by a measurement called Cobb's method, which measured the angle between the superior endplate of the upper vertebrae and the inferior endplate of the lower vertebrae. Use this to assess the degree of local kyphosis of the spine.

  One day before operation, one day after operation and 1year.

Secondary Outcomes (2)

• Change from Baseline the disc height anterior

  One day before operation, one day after operation and 1year.

• Change from Baseline the disc height posterior

  One day before operation, one day after operation and 1year.

Study Arms (2)

PVDP group

EXPERIMENTAL

Patients underwent percutaneous vertebral-disc plasty

Procedure: percutaneous vertebral-disc plasty

PVP group

NO INTERVENTION

Patients underwent conventional percutaneous vertebroplasty

Interventions

percutaneous vertebral-disc plasty PROCEDURE

percutaneous vertebroplasty combined percutaneous cement discoplasty

PVDP group

Eligibility Criteria

• Age: 58 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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.

You may not qualify 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.

Sponsors & Collaborators

• Jiawei Jiang: lead

Study Sites (1)

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, 0513, China

RECRUITING

Study Officials

• Guanhua Xu, Dr

  Affiliated 2 Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiawei Jiang, Dr

CONTACT

18862802782; 18862802782@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 29, 2022
• Study Start: March 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)