NCT02700308

A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors
• Spine Metastasis

Interventions

Type	Name	Description
DEVICE	Kyphoplasty	Placement and inflation of balloon prior to cement injection
DEVICE	Conventional vertebroplasty	Conventional vertebroplasty

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-03-07
• Last updated: 2022-07-28

Locations

2 sites across 1 country: France