A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
NCT ID: NCT02700308
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2016-03-31
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional vertebroplasty
Conventional vertebroplasty (device's trade at the discretion of the investigator)
Conventional vertebroplasty
Conventional vertebroplasty
Kyphoplasty
Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)
Kyphoplasty
Placement and inflation of balloon prior to cement injection
Interventions
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Kyphoplasty
Placement and inflation of balloon prior to cement injection
Conventional vertebroplasty
Conventional vertebroplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2 metastatic sites or more;
* Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
* Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
* Pain equal or greater than 4/10 at Visual Analogic Scale
* Unstable vertebrae (SINS score equal or greater than 7;
* Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2
Exclusion Criteria
* Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
* Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
* Neurological deficit due to medullar or radicular compression;
* Participation to another clinical trial with an analgesic intent.
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Amine BOUHAMAMA, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard
Lyon, , France
Hopital Nord
Saint-Etienne, , France
Countries
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Other Identifiers
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ET14000050
Identifier Type: -
Identifier Source: org_study_id
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