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

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 |

Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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.
- 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).

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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 |
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

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
Netherlands | |
Albert Schweitzer Ziekenhuis | |
Dordrecht, Netherlands, 3300AK | |
Catharina Ziekenhuis | |
Eindhoven, Netherlands, 5623EJ | |
Medisch Spectrum Twente | |
Enschede, Netherlands, 7500KA | |
St. Elisabeth Ziekenhuis | |
Tilburg, Netherlands, 5022GC |
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 |
Responsible Party: | Willem Jan van Rooij, WJ van Rooij, St. Elisabeth Ziekenhuis., Elisabeth-TweeSteden Ziekenhuis |
ClinicalTrials.gov Identifier: | NCT01200277 |
Other Study ID Numbers: |
EZTilburg1 |
First Posted: | September 13, 2010 Key Record Dates |
Last Update Posted: | November 18, 2014 |
Last Verified: | November 2014 |
osteoporosis vertebral fracture vertebroplasty percutaneous |
Osteoporosis Fractures, Bone Spinal Fractures Wounds and Injuries Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases Metabolic Diseases Spinal Injuries Back Injuries |