Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

Peking University

Status: Unknown

Conditions: Spinal Fractures

Treatments: Procedure: percutaneous vertebroplasty; Procedure: conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03360383

AVCF1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

grade 1

Experimental group

Description:

percutaneous vertebroplasty

Treatment:

Procedure: percutaneous vertebroplasty

grade 2

Active Comparator group

Description:

conservative treatment

Treatment:

Procedure: conservative treatment