Status:
TERMINATED
Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
One or Two Traumatic Vertebral Fractures
Located Between T11 and L5
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surge...
Detailed Description
Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal d...
Eligibility Criteria
Inclusion
- Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)
- Patient must have signed the consent form
- Male or female patient aged 18 or over
- One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle \> 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression
- Fracture with or without neurological difficulties
- Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure.
Exclusion
- Non- traumatic, malignant or osteoporotic vertebral fractures
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
- More than two recent vertebral fractures
- Current infection
- Impossibility to perform the percutaneous approach of the vertebra to treat.
- Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat.
- Vertebral fracture with loss of 90%or more of the vertebral body height
- Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
- Evolutive cardiac disease nonreactive to medical treatment
- Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
- Pregnant or breast feeding women
- Patient not affiliated to social security
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00749229
Start Date
December 1 2007
End Date
March 1 2011
Last Update
January 4 2017
Active Locations (1)
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1
Service de Radiologie, Hôpital Lariboisière
Paris, France, 75010