A randomised sham controlled trial of vertebroplasty for painful chronic osteoporotic vertebral fractures

A randomised sham controlled trial of vertebroplasty for painful chronic osteoporotic vertebral fractures - VERTOS V

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47294

Enrollment

Registered

2013-06-13

Start date

2013-05-24

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporotic vertebral fracture vertebral compression fracture

Interventions

Procedure/Surgery: percutaneous vertebroplasty Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •VCF on X-ray of the spine (minimal 15% loss of height) •level of VCF Th5 or lower •back pain = 50 years of age •bone edema on MRI of the fractured vertebral body •focal tenderness on VCF level •decreased bone density T-scores

Exclusion criteria

Exclusion criteria: •severe cardio-pulmonary condition •untreatable coagulopathy •systemic or local infection of the spine (osteomyelitis, spondylodiscitis) •suspected alternative underlying disease (malignancy) •radicular and/or cauda compression syndrome •contra-indication for MRI

Design outcomes

Primary

Measure	Time frame
Primary outcome will be pain relief at 1 day, 1 week, and 1,3, 6 and 12 months. The questionnaire consist of the VAS score and questions about use of pain medication, pain location, and pain type. Other medical treatment and visits to alternative medical specialists, GP's and physical therapists are recorded and compared between groups. Patients are asked to fill out the VAS score and use of analgesics is recorded on a daily basis during the first month after randomization.	—

Measure

Time frame

Primary outcome will be pain relief at 1 day, 1 week, and 1,3, 6 and 12 months. The questionnaire consist of the VAS score and questions about use of pain medication, pain location, and pain type. Other medical treatment and visits to alternative medical specialists, GP's and physical therapists are recorded and compared between groups. Patients are asked to fill out the VAS score and use of analgesics is recorded on a daily basis during the first month after randomization.

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Secondary

Measure	Time frame
Back pain related disability as measured with the Roland Morris Disability (RMD) Questionnaire. The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain. The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions. Description: QOL as measured with the Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The Qualeffo score ranges from 0 (best quality of life) to 100 (worst quality of life). This questionnaire will be completed at five measurement moments (before and at 1, 3, 6 and 12 months after the procedure).	—

Measure

Time frame

Back pain related disability as measured with the Roland Morris Disability (RMD) Questionnaire. The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain. The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions. Description: QOL as measured with the Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The Qualeffo score ranges from 0 (best quality of life) to 100 (worst quality of life). This questionnaire will be completed at five measurement moments (before and at 1, 3, 6 and 12 months after the procedure).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)