Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporot… (NCT00749060) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
France48 participantsStarted 2007-12
Plain-language summary
This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.