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VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy

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ClinicalTrials.gov Identifier: NCT00232466
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : February 15, 2018
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Clinical Research Office Imaging Division, UMC Utrecht

Brief Summary:

Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.


This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.

Study population:

Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score < -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging

Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.

Economic evaluation:

Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.

Time schedule:

The total study will take 36 months

Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.

Condition or disease Intervention/treatment
Osteoporosis Back Pain Procedure: Vertebroplasty

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
Study Start Date : February 2006
Study Completion Date : June 2010

Arm Intervention/treatment
No Intervention: 2
conservative therapy (no intervention)
Active Comparator: 1
Procedure: Vertebroplasty


The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body (maximal 2 vertebrae in 1 treatment session) using fluoroscopic guidance. The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay.

Primary Outcome Measures :
  1. To compare the cost-effectivity in the two groups [ Time Frame: 1 month, 1 year ]
  2. VAS score in time [ Time Frame: 1 month, 1 year ]

Secondary Outcome Measures :
  1. To compare pain relief and the quality of life of the patients in the two groups. [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • age: 50 and older
  • vertebral fracture: 15-85% height loss
  • level: thoracic vertebral body 5 (Th 5) or lower
  • osteopenia (T-score < -1 SD)
  • back pain for at least no longer than 6 weeks
  • edema in the vertebrae on MR imaging

Exclusion criteria:

  • complete loss of vertebral body height
  • fracture through or destruction of the posterior vertebral wall
  • pressure of bone fragments on the spinal cord
  • osteomyelitis or spondylodiscitis
  • vertebral column neoplasms
  • uncorrectable coagulation disorder
  • medical conditions that would make the patient ineligible for emergency decompressive surgery should it be necessary to treat a complication of the procedure

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): NCT00232466

AZ St. Lucas Ziekenhuis
Gent, Belgium, 9000
Utrecht/Zeist/Doorn, Utrecht, Netherlands, 3508 TG
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands, 3300 AK
Eindhoven, Netherlands, 5623 EJ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Clinical Research Office Imaging Division
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Willem Mali, MD.PhD UMC Utrecht

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

Responsible Party: Clinical Research Office Imaging Division, Clinical research coordinator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00232466     History of Changes
Other Study ID Numbers: 945-06-351
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: June 2008

Keywords provided by Clinical Research Office Imaging Division, UMC Utrecht:
Vertebral fracture

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases