Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Primary Endpoint
- change of pain relief
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
grade 2
conservative treatment
Intervention: conservative treatment (Procedure)
grade 1
percutaneous vertebroplasty
Intervention: percutaneous vertebroplasty (Procedure)
Outcomes
Primary Outcomes
change of pain relief
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
World Health Organization pain classification
Secondary Outcomes
- quality of life(1 day, 1 week, 1 month, 3 months, 6 months, and 1 year)
Investigators
Liu Haiying
Director department of spinal surgery
Peking University People's Hospital