Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00749060
Eligibility Criteria:
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 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 NFSā„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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00749060
Study Brief:
Protocol Section:
NCT00749060