Clinical Trial: A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Centre Leon Berard

Current Primary Outcome: Success rate for each strategy [ Time Frame: 3 months after the procedure ]

The success rate will be calculated with the proportion of patients without cement leakage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: The day after the procedure ]
    Pain will be assessed using a Visual Analogic Scale
  • Analgesic properties of the strategies at 21 days [ Time Frame: 21 days after the procedure ]
    Pain will be assessed using a Visual Analogic Scale
  • Analgesic properties of the strategies at the end of the study [ Time Frame: 3 months after the procedure ]
    Pain will be assessed using a Visual Analogic Scale
  • Tolerance profile of the strategies [ Time Frame: Through study completion ]
    Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4
  • Type of cement leakage (vascular versus cortical localisation) [ Time Frame: 3 months after the procedure ]
    Location will be described as vascular or cortical using the imaging assessments
  • Size of cement leakage [ Time Frame: 3 months after the procedure ]
    Size will be described as significant or not significant as per investigator judgement
  • Symptoms associated with cement leakage [ Time Frame: 3 months after the procedure ]
    Symptoms associated with cement leakage will be tolerance events that are stated by the investigator as related to a cement leakage
  • Quality of Life in both arms at Day 21 [ Time Frame: 21 days after procedure ]
    Quality of Life will be assessed with the Dallas questionnaire for spinal pain
  • Quality of Life in both arms at the end oh study [ Time Frame: 3 months after the procedure ]
    Quality of Life will be assessed with the Dallas questionnaire for spinal pain
  • Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale [ Time Frame: 3 months after the procedure ]


Original Secondary Outcome: Same as current

Information By: Centre Leon Berard

Dates:
Date Received: October 27, 2015
Date Started: March 2016
Date Completion: October 2018
Last Updated: March 1, 2016
Last Verified: March 2016