Clinical Trial: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

Brief Summary:

The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.

Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.

An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.

The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire Dijon

Current Primary Outcome: Measure of Spinal kyphosis angle [ Time Frame: Between the post-operative period (D1) and a minimum of one year of follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of pain (VAS) [ Time Frame: At least 1 year after the kyphoplasty ]
  • Number of new vertebral fractures [ Time Frame: At least 1 year after the kyphoplasty ]
  • Evaluation of quality of life (OSWESTRY and EIFEL) [ Time Frame: At least 1 year after the kyphoplasty ]
  • Evolution of the regional angle of vertebral kyphosis [ Time Frame: At least 1 year after the kyphoplasty ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire Dijon

Dates:
Date Received: March 5, 2014
Date Started: June 2013
Date Completion:
Last Updated: March 12, 2014
Last Verified: June 2013