Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

Not Applicable

• Conditions: Spinal Fractures
• Interventions: Procedure: percutaneous vertebroplasty; Procedure: conservative treatment

• Registration Number: NCT03360383
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.

Detailed Description

This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.

Study Timeline

• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-02
• Study First Posted: 2017-12-04
• Last Update Posted: 2017-12-05
• Study Start: 2018-02-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• vertebral compression fracture on spine radiograph (minimum 15% height loss)
• level of fracture at Th5 or lower; back pain for 6 weeks or less
• focal tenderness at fracture level on physical examination
• bone oedema of vertebral fracture on MRI
• decreased bone density (T scores ≤-1)

Exclusion Criteria

• severe cardiopulmonary comorbidity
• suspected underlying malignant disease
• radicular syndrome
• spinal-cord compression syndrome
• contraindication for radiography exam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grade 1	percutaneous vertebroplasty	percutaneous vertebroplasty
grade 2	conservative treatment	conservative treatment

Primary Outcome Measures

Name	Time	Method
change of pain relief	1 day, 1 week, 1 month, 3 months, 6 months, and 1 year	World Health Organization pain classification

Secondary Outcome Measures

Name	Time	Method
quality of life	1 day, 1 week, 1 month, 3 months, 6 months, and 1 year	Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)