VASO - Vitamin D and Arthroplasty Surgery Outcomes (v.1)
Research type
Research Study
Full title
A prospective, randomised-controlled feasibility study investigating the benefit of screening for Vitamin D deficiency in a pre-operative elective arthroplasty setting.
IRAS ID
216934
Contact name
Mike Reed
Contact email
Sponsor organisation
Northumbria Healthcare Research and Development
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Vitamin D deficiency or insufficiency is common in adults in the UK, particularly during the winter months where over 50% of adults are thought to have low a Vitamin D level. There is reported evidence that patients who have a low Vitamin D level may have a poorer outcome, longer length of stay, and lower patient reported outcome measure scores (PROMS) following total hip or knee replacement surgery. We are going to investigate if we should check patient's Vitamin D levels prior to surgery, as one way of helping to improve outcomes. 180,000 total hip or knee replacement procedures are performed each year in the UK and so if a link exists, the benefits of screening may be significant. We think that patients should be screened for Vitamin D deficiency, and if they are found to be deficient then to start oral supplementation prior to surgery and continue until 6 months after surgery.
We will measure the Vitamin D level of 100 patients recruited to this study, when they are added to the waiting list for a total hip or knee replacement. Those patients who have a Vitamin D level below normal will be randomised to one of 2 groups; either to receive Vitamin D supplementation before surgery or not. We will follow the three groups of patients [ (1) those with a normal Vitamin D level, (2) those with a low Vitamin D level and don't receive supplementation, and (3) those with a low Vitamin D level who do receive supplementation ] until 6 months after surgery when they complete their PROMS, which are routine questionnaires sent out by NHS digital following hip or knee surgery. This feasibility study will help us plan a larger, multi-centre study to investigate the effect of normalising Vitamin D levels prior to hip or knee replacement.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0067
Date of REC Opinion
13 Mar 2017
REC opinion
Further Information Favourable Opinion