Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures

Hospital Clinic of Barcelona

Status: Completed

Conditions: Osteoporosis; Back Pain; Spinal Fracture

Treatments: Procedure: percutaneous injection of cement into the vertebral body; Other: Medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00994032

HCPB-VP

Details and patient eligibility

About

The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.

Full description

Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.

In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
• Fragility; i.e. fracture not in relation with significant trauma
• Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion criteria

• No vertebral edema on STIR MR images
• Uncorrectable bleeding diatheses
• Active infection
• Substantial retropulsion of bony fragments
• Non-osteoporotic fracture
• Concomitant neoplasm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

vertebroplasty

Active Comparator group

Treatment:

Procedure: percutaneous injection of cement into the vertebral body

Medical Treatment

Active Comparator group

Treatment:

Other: Medical treatment