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A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases — KYPHO-01  

Solid Tumors Clinical Trial

Official title:
A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02700308
Study type Interventional
Source Centre Leon Berard
Contact
Status Terminated
Phase Phase 2
Start date March 2016
Completion date December 2020
View Details
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