Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture. The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments. Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space. In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage. To date, no data from randomized study are available in the population of cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Placement and inflation of balloon prior to cement injection
Conventional vertebroplasty
Centre Léon Bérard
Lyon, France
Hopital Nord
Saint-Etienne, France
Success rate for each strategy
The success rate will be calculated with the proportion of patients without cement leakage
Time frame: 3 months after the procedure
Height of the targeted vertebrae
Time frame: 3 months after the procedure
Height of the patient
Time frame: 3 months after the procedure
Kyphotic angle
Time frame: 3 months after the procedure
Analgesic properties of the strategies the day after the procedure
Pain will be assessed using a Visual Analogic Scale
Time frame: The day after the procedure
Analgesic properties of the strategies at 21 days
Pain will be assessed using a Visual Analogic Scale
Time frame: 21 days after the procedure
Analgesic properties of the strategies at the end of the study
Pain will be assessed using a Visual Analogic Scale
Time frame: 3 months after the procedure
Tolerance profile of the strategies
Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4
Time frame: Through study completion
Type of cement leakage (vascular versus cortical localisation)
Location will be described as vascular or cortical using the imaging assessments
Time frame: 3 months after the procedure
Size of cement leakage
Size will be described as significant or not significant as per investigator judgement
Time frame: 3 months after the procedure
Symptoms associated with cement leakage
Symptoms associated with cement leakage will be tolerance events that are stated by the investigator as related to a cement leakage
Time frame: 3 months after the procedure
Quality of Life in both arms at Day 21
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Time frame: 21 days after procedure
Quality of Life in both arms at the end oh study
Quality of Life will be assessed with the Dallas questionnaire for spinal pain
Time frame: 3 months after the procedure
Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale
Time frame: 3 months after the procedure
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