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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02700308
Other study ID # ET14000050
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date December 2020

Study information

Verified date July 2022
Source Centre Leon Berard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas; - 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: - Contraindication to vertebroplasty, including contraindication to cement use; - 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.

Study Design


Intervention

Device:
Kyphoplasty
Placement and inflation of balloon prior to cement injection
Conventional vertebroplasty
Conventional vertebroplasty

Locations

Country Name City State
France Centre Léon Bérard Lyon
France Hopital Nord Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate for each strategy The success rate will be calculated with the proportion of patients without cement leakage 3 months after the procedure
Secondary Height of the targeted vertebrae 3 months after the procedure
Secondary Height of the patient 3 months after the procedure
Secondary Kyphotic angle 3 months after the procedure
Secondary Analgesic properties of the strategies the day after the procedure Pain will be assessed using a Visual Analogic Scale The day after the procedure
Secondary Analgesic properties of the strategies at 21 days Pain will be assessed using a Visual Analogic Scale 21 days after the procedure
Secondary Analgesic properties of the strategies at the end of the study Pain will be assessed using a Visual Analogic Scale 3 months after the procedure
Secondary Tolerance profile of the strategies Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4 Through study completion
Secondary Type of cement leakage (vascular versus cortical localisation) Location will be described as vascular or cortical using the imaging assessments 3 months after the procedure
Secondary Size of cement leakage Size will be described as significant or not significant as per investigator judgement 3 months after the procedure
Secondary 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 3 months after the procedure
Secondary Quality of Life in both arms at Day 21 Quality of Life will be assessed with the Dallas questionnaire for spinal pain 21 days after procedure
Secondary Quality of Life in both arms at the end oh study Quality of Life will be assessed with the Dallas questionnaire for spinal pain 3 months after the procedure
Secondary Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale 3 months after the procedure
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