A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures (VertosIV)

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ClinicalTrials.gov Identifier: NCT01200277

Recruitment Status : Completed

First Posted : September 13, 2010

Last Update Posted : November 18, 2014

Sponsor:

Information provided by (Responsible Party):

Willem Jan van Rooij, Elisabeth-TweeSteden Ziekenhuis

Study Description

Brief Summary:

The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.

Condition or disease	Intervention/treatment	Phase
Osteoporosis Vertebral Fracture	Procedure: percutaneous vertebroplasty Procedure: sham procedure	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures
Study Start Date :	January 2011
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Osteoporosis Spine Injuries and Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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 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.	Procedure: 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 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.
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 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 is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.

Arm

Intervention/treatment

Experimental: 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 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.

Procedure: 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 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.

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 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 is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.

Outcome Measures

Primary Outcome Measures :

pain relief [ Time Frame: 12 months ]
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.

Secondary Outcome Measures :

back pain related disability [ Time Frame: 0, 1day, 1 week, 1,3,6,12 months ]
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.
Quality of Life [ Time Frame: 1 week, 1,3,6,12 months ]
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).

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

VCF on X-ray of the spine (minimal 15% loss of height)
level of VCF Th5 or lower
back pain ≤ 6 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200277

Locations

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Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3300AK
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
Medisch Spectrum Twente
Enschede, Netherlands, 7500KA
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022GC

Sponsors and Collaborators

Elisabeth-TweeSteden Ziekenhuis

Investigators

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Study Director:	Willem Jan van Rooij, PhD	St. Elisabeth Ziekenhuis
Principal Investigator:	Paul N Lohle, PhD	St Elisabeth Ziekenhuis
Study Director:	Jolanda De Vries, PhD	St Elisabeth Ziekenhuis

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Firanescu CE, de Vries J, Lodder P, Schoemaker MC, Smeets AJ, Donga E, Juttmann JR, Klazen CAH, Elgersma OEH, Jansen FH, van der Horst I, Blonk M, Venmans A, Lohle PNM. Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV). Cardiovasc Intervent Radiol. 2019 Apr 2. doi: 10.1007/s00270-019-02205-w. [Epub ahead of print]

Firanescu CE, de Vries J, Lodder P, Venmans A, Schoemaker MC, Smeets AJ, Donga E, Juttmann JR, Klazen CAH, Elgersma OEH, Jansen FH, Tielbeek AV, Boukrab I, Schonenberg K, van Rooij WJJ, Hirsch JA, Lohle PNM. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551. doi: 10.1136/bmj.k1551. Erratum in: BMJ. 2018 Jul 4;362:k2937. Smeet AJ [corrected to Smeets AJ].

Firanescu C, Lohle PN, de Vries J, Klazen CA, Juttmann JR, Clark W, van Rooij WJ; VERTOS IV study group. A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV). Trials. 2011 Apr 5;12:93. doi: 10.1186/1745-6215-12-93.

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Responsible Party:	Willem Jan van Rooij, WJ van Rooij, St. Elisabeth Ziekenhuis., Elisabeth-TweeSteden Ziekenhuis
ClinicalTrials.gov Identifier:	NCT01200277 History of Changes
Other Study ID Numbers:	EZTilburg1
First Posted:	September 13, 2010 Key Record Dates
Last Update Posted:	November 18, 2014
Last Verified:	November 2014

Keywords provided by Willem Jan van Rooij, Elisabeth-TweeSteden Ziekenhuis:


osteoporosis vertebral fracture vertebroplasty percutaneous

Additional relevant MeSH terms:

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Fractures, Bone Osteoporosis Spinal Fractures Wounds and Injuries Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Spinal Injuries Back Injuries Bupivacaine Lidocaine	Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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