A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

Osteoporosis Clinical Trial

— VERTOSV  

Official title:

A Randomised Sham Controlled Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963039
• Other study ID #: EZTilburg2
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: September 3, 2020

Study information

• Verified date: November 2020
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• VCF on X-ray of the spine (minimal 15% loss of height)
• level of VCF Th5 or lower
• back pain = 12 weeks at time of X-ray
• = 50 years of age
• bone edema on MRI of the fractured vertebral body
• focal tenderness on VCF level
• decreased bone density T-scores = -1

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Spinal Fractures
• Vertebral Fracture

Intervention

Device:
• percutaneous vertebroplasty
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.

Procedure:
• Sham procedure
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer (PMMA) is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.

Locations

Country	Name	City	State
Netherlands	Elisabeth Tweesteden Ziekenhuis	Tilburg

Sponsors (3)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	Medtronic, Stryker Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Primary outcome will be pain score at 1 day, 1 week, and 1,3, 6 and 12 months after PV compared to baseline pain score. 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.	12 months
Secondary	Back pain related disability	Back pain related disability as measured with the Roland Morris Disability (RMD) Questionnaire. 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 RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain.	0, 1day, 1 week, 1,3,6,12 months
Secondary	Quality of Life	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).	1 week, 1,3,6,12 months