Status:
COMPLETED
Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Osteoporotic Vertebral Fracture
Between T5 and L5
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
Detailed Description
The three treatments are the following: 1/Conventional medical treatment including rest and pain medications2/Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of pol...
Eligibility Criteria
Inclusion
- Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure
- Patient must have signed the consent form (ZELEN Randomization protocol)
- Male or female, 50 years or older
- One or two non-traumatic vertebral fracture(s):
- Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm)
- Fracture(s) of less than 6 weeks duration after the onset of pain related to the fracture The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI
- The patient will be able to receive the selected protocol treatment within 6 weeks after onset of fracture-related symptoms and within 15 days after treatment randomization.
- The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty or by one year follow-up in the conservative treatment group.
Exclusion
- Patient with a vertebral fracture of more than 6 week duration after onset of fracture-related symptoms.
- Neurological signs related to the vertebral fracture to treat
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- 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.
- Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
- Vertebral fracture with loss of 90%or more of the vertebral body height
- Neurological signs or symptoms related to the vertebral fracture
- Malignant and traumatic vertebral fractures
- Contraindication to MRI :
- Metallic implant : pace-maker, non movable auditive implant, metallic vascular or cardiac device
- Metallic surgical clips
- Claustrophobia
- Evolutive cardiac disease nonreactive to medical treatment
- Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
- Presence of an unexplained biological inflammatory syndrome with NFS≥20
- 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 :
June 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00749060
Start Date
December 1 2007
End Date
June 1 2012
Last Update
December 16 2014
Active Locations (1)
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1
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, France, 75010