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WITHDRAWN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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