Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture

Not Applicable

• Conditions: Osteoporosis Fracture; Compression Fracture Spine
• Interventions: Other: Pillow

• Registration Number: NCT03451305
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-23
• Status Verified: 2018-02
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Study First Posted: 2018-03-01
• Last Update Posted: 2018-03-01
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Single level osteoporotic compression fracture of thoracic and lumbar spine

Exclusion Criteria

• Can't tolerate the postural reduction by pillow
• Pathological spine fracture caused by tumor, infection.
• Multiple spine fractures
• Patient presented with neurological. deficits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pillow group	Pillow	Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day.

Primary Outcome Measures

Name	Time	Method
Sagittal plane contour	6 months of post-operative follow up	Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs

Secondary Outcome Measures

Name	Time	Method
Functional outcome	6 months of post-operative follow up	Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan