NCT00232466

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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 15, 2018

Status Verified

June 1, 2008

First QC Date

September 30, 2005

Last Update Submit

February 14, 2018

Conditions

OsteoporosisBack Pain

Keywords

VertebroplastyVertebral fractureActonelOsteoporoticvertebralfractures

Outcome Measures

Primary Outcomes (2)

  • To compare the cost-effectivity in the two groups

    1 month, 1 year

  • VAS score in time

    1 month, 1 year

Secondary Outcomes (1)

  • To compare pain relief and the quality of life of the patients in the two groups.

    1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 24 months

Study Arms (2)

2

NO INTERVENTION

conservative therapy (no intervention)

1

ACTIVE COMPARATOR

Vertebroplasty

Procedure: Vertebroplasty

Interventions

VertebroplastyPROCEDURE

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.

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AZ St. Lucas Ziekenhuis

Ghent, 9000, Belgium

Location

Diakonessenhuis

Utrecht/Zeist/Doorn, Utrecht, 3508 TG, Netherlands

Location

Albert Schweizer Ziekenhuis

Dordrecht, 3300 AK, Netherlands

Location

Catharina-Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

UMCU

Utrecht, 3508 GA, Netherlands

Location

Related Publications (4)

  • Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.

    PMID: 20701962DERIVED

  • Klazen CA, Venmans A, de Vries J, van Rooij WJ, Jansen FH, Blonk MC, Lohle PN, Juttmann JR, Buskens E, van Everdingen KJ, Muller A, Fransen H, Elgersma OE, Mali WP, Verhaar HJ. Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2010 Sep;31(8):1447-50. doi: 10.3174/ajnr.A2148. Epub 2010 Jul 22.

    PMID: 20651016DERIVED

  • Venmans A, Klazen CA, Lohle PN, van Rooij WJ, Verhaar HJ, de Vries J, Mali WP. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. AJNR Am J Neuroradiol. 2010 Sep;31(8):1451-3. doi: 10.3174/ajnr.A2127. Epub 2010 May 20.

    PMID: 20488908DERIVED

  • Klazen CA, Verhaar HJ, Lampmann LE, Juttmann JR, Blonk MC, Jansen FH, Tielbeek AV, Schoemaker MC, Buskens E, van der Graaf Y, Janssens X, Fransen H, van Everdingen KJ, Muller AF, Mali WP, Lohle PN. VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. Trials. 2007 Oct 31;8:33. doi: 10.1186/1745-6215-8-33.

    PMID: 17973983DERIVED

Related Links

MeSH Terms

Conditions

OsteoporosisBack PainSpinal FracturesFractures, Bone

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal InjuriesBack InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

CementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Willem Mali, MD.PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical research coordinator

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

February 1, 2006

Study Completion

June 1, 2010

Last Updated

February 15, 2018

Record last verified: 2008-06

Locations

NL(5)BE(1)