VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00232466
First received: September 30, 2005
Last updated: June 24, 2008
Last verified: June 2008
  Purpose

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.

Design:

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 Intervention
Osteoporosis
Back Pain
Procedure: Vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • To compare the cost-effectivity in the two groups [ Time Frame: 1 month, 1 year ] [ Designated as safety issue: No ]
  • VAS score in time [ Time Frame: 1 month, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
conservative therapy (no intervention)
Active Comparator: 1
Vertebroplasty
Procedure: Vertebroplasty

Procedure:

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232466

Locations
Belgium
AZ St. Lucas Ziekenhuis
Gent, Belgium, 9000
Netherlands
Diakonessenhuis
Utrecht/Zeist/Doorn, Utrecht, Netherlands, 3508 TG
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands, 3300 AK
Catharina-Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
UMCU
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Willem Mali, MD.PhD UMC Utrecht
  More Information

Additional Information:
No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caroline Klazen, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00232466     History of Changes
Other Study ID Numbers: 945-06-351, 945-06-351
Study First Received: September 30, 2005
Last Updated: June 24, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Vertebroplasty
Vertebral fracture
Actonel
Osteoporotic
vertebral
fractures

Additional relevant MeSH terms:
Back Pain
Osteoporosis
Spinal Fractures
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on August 28, 2014