Vertebroplasty In TRAuma (VITRA) pilot study
Research type
Research Study
Full title
A feasibility study comparing non-surgical management and percutaneous vertebroplasty in the treatment of acute, non-osteoporotic, traumatic vertebral compression fractures
IRAS ID
131563
Contact name
Paul J Maliakal
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Research summary
A feasibility study comparing non-surgical management versus percutaneous vertebroplasty (a minimally invasive procedure, which involves injection of bone cement (PMMA) into the vertebral body) in the treatment of acute, non-osteoporotic, traumatic vertebral compression fractures
This is a pilot study, translating the use of vertebroplasty (VP) from the context of osteoporotic and oncological fractures to the treatment of non-osteoporotic traumatic fractures.
The primary and secondary objectives are to measure the (i) efficacy and safety and (ii) cost-effectiveness of VP with optimal pain management (OPM) and physiotherapy, against the current best practice (OPM, physiotherapy and bracing) . All patients referred to the neurosurgical unit with possible non-osteoporotic fracture of the thoracic and/or lumbar vertebrae will be assessed for eligibility to the study. Those patients who meet the inclusion criteria and agree to participate, will be randomised into one of the two groups and undergo a CT +/- an MRI scan, intervention and subsequent follow-up for one year, with assessments of clinical and functional outcomes, patient satisfaction and complications at 1 day, 2 weeks, 2 and 6 months and 1 year. Radiographic stability will be assessed at 2 weeks by a consultant neuroradiologist. Data will be analysed on an intention-to-treat basis so that all patients starting the study will be included, even if they do not finish.REC name
North East - York Research Ethics Committee
REC reference
13/NE/0350
Date of REC Opinion
15 Jan 2014
REC opinion
Further Information Favourable Opinion