Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedDecember 5, 2017
December 1, 2017
1.9 years
November 25, 2017
December 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of pain relief
World Health Organization pain classification
1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Secondary Outcomes (1)
quality of life
1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Study Arms (2)
grade 1
EXPERIMENTALpercutaneous vertebroplasty
grade 2
ACTIVE COMPARATORconservative treatment
Interventions
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
haiying liu
PekingUPH department of spinal surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director department of spinal surgery
Study Record Dates
First Submitted
November 25, 2017
First Posted
December 4, 2017
Study Start
February 1, 2018
Primary Completion
January 1, 2020
Study Completion
June 1, 2020
Last Updated
December 5, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share