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
- Conditions
- Thoracolumbar Spine
- Interventions
- Other: radiography standard
- Registration Number
- NCT02085811
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Men or women aged at least 18;
- who underwent Kyphoplasty between T11 and L5,
- Patients who had Kyphoplasty at a single level without associated surgery,
- Magerl type-A fracture.
- Non-tumoral and non-osteoporotic cause.
Exclusion Criteria
- Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
- Osteoporotic vertebral fracture
- Association with other post-traumatic fractures.
- History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
- Pregnant or breast-feeding women
- Patients not covered by national health insurance
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients radiography standard -
- Primary Outcome Measures
Name Time Method Measure of Spinal kyphosis angle Between the post-operative period (D1) and a minimum of one year of follow-up
- Secondary Outcome Measures
Name Time Method Evaluation of pain (VAS) At least 1 year after the kyphoplasty Number of new vertebral fractures At least 1 year after the kyphoplasty Evaluation of quality of life (OSWESTRY and EIFEL) At least 1 year after the kyphoplasty Evolution of the regional angle of vertebral kyphosis At least 1 year after the kyphoplasty
Trial Locations
- Locations (1)
CHU de DIJON
🇫🇷Dijon, France