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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Vertebral Fracture
• Intervention / Treatment: Device: percutaneous vertebroplasty; Procedure: Sham procedure

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth Tweesteden ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 (PMMA) is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the cement reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.	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.; Other Names: § 888.302713 Polymethylmethacrylate (PMMA) Bone Cement.
Sham Comparator: 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 bone cement(PMMA) is prepared to simulate the odor associated with mixing of polymethacrylate , but the needle is not placed and cement is not injected.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Elisabeth-TweeSteden Ziekenhuis
• Collaborators: Medtronic; Stryker Medical
• Investigators: Principal Investigator: Dennis Carli, drs, Elisabeth Tweesteden Ziekenhuis/ SJG Weert; Study Director: Paul Lohle, dr., Elisabeth-TweeSteden Ziekenhuis

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 3, 2020
• Study Completion (Actual): September 3, 2020

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Fractures, Bone; Osteoporosis; Spinal Fractures; Physiological Effects of Drugs; Vasodilator Agents; Protective Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: EZTilburg2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No