VITTA


 

Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of acute vertebral fractures.

The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful vertebral compression fractures

Study Type:

Interventional

Study Design:

Allocation: Randomized

Endpoint Classification:  Efficacy Study

Intervention Model: Crossover Assignment

Masking: double blind (Subject, Outcomes Assessor)

Primary Purpose: Treatment

Official Title:

Vertebroplasty In The Treatment Of Acute Fracture Trial – VITTA Trial

 

Primary endpoint

Achieving a score of 75 or higher on the Barthel Index functional evaluation score at 15 days.

Primary Hypothesis

The proportion of patients achieving a score of 75 or higher on the Barthel Index functional evaluation score at 15 days will be 30% higher in the vertebroplasty group compared with the facet block group.

Secondary Hypothesis

Patients receiving vertebroplasty will have lower rates of cross-over at 15 days, lower pain levels at 15 and at 30 days and higher functional status at 30 days compared with patients receiving facet block. 

The proportion of patients who are dwelling at home will be higher among the vertebroplasty group.



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