- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03360383
Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures
Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: grade 1
percutaneous vertebroplasty
|
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
|
ACTIVE_COMPARATOR: grade 2
conservative treatment
|
complete on bed with prevention of complications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of pain relief
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
|
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
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
|
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
|
1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVCF1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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