Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial

Conditions
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Spinal Fractures

Intervention / Treatment
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* Procedure: percutaneous vertebroplasty
* Procedure: conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: grade 1<br>percutaneous vertebroplasty | Procedure: percutaneous vertebroplasty<br>* Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.<br>|
| Active Comparator: grade 2<br>conservative treatment | Procedure: conservative treatment<br>* complete on bed with prevention of complications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain relief | World Health Organization pain classification | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Fractures/surgery, Vertebroplasty, Quality-Adjusted Life Years