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Status:

WITHDRAWN

Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Vertebral Body Compression Fractures

Eligibility:

All Genders

50+ years

Phase:

NA

Brief Summary

The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via ky...

Eligibility Criteria

Inclusion

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 3 months of follow-up
  • Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
  • Cyphose of \>10°
  • Spinal pain
  • Vertebral fracture \< 3 weeks old located between D5 and L5
  • If fragments in the canal, they must protrude less than 40%
  • Absence of other lesions, including cancer

Exclusion

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Patient cannot read French
  • Patient is pregnant or breast feeding
  • Patient has a fracture on an adjacent vertebra
  • Patient has a contra-indication for a treatment used in this study
  • ASA class IV or V
  • Patient has a neurological deficit
  • Previous spinal surgery

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2016

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01402167

Start Date

September 1 2014

End Date

August 1 2016

Last Update

March 25 2015

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