Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

BACKGROUND: Vitamin D deficiency has been linked to poor outcomes after total hip replacement (THR) or total knee replacement (TKR), including lower patient-reported outcome measures (PROMs), peri-prosthetic infection and longer hospital stay. We present a randomised feasibility trial protocol designed to prospectively investigate the influence of vitamin D testing, and subsequent supplementation for deficiency, prior to THR/TKR. METHODS/DESIGN: One hundred adult patients undergoing primary THR/TKR for osteoarthritis at two NHS hospital trusts in North East England will be recruited. Exclusion criteria include lack of mental capacity, revision surgery, participants already taking vitamin D/calcium supplements, or a known contraindication to vitamin D treatment. Participants will be ineligible for the trial if they have an estimated glomerular filtration rate < 30 ml/minute. We will measure patients' vitamin D levels at baseline, and those identified as deficient (vitamin D < 50 nmol/L) will be randomised to receive either vitamin D supplementation or no supplementation prior to, and for 6 months following, surgery. Patients with a normal vitamin D level (≥50 nmol/L) will receive no supplementation. Vitamin D levels will be rechecked on the day of surgery and again at 6 months. Patients will also complete a lifestyle questionnaire, as well as the Oxford hip or knee and EQ-5D-3 L PROM questionnaires, at baseline and at 6 months following surgery. The aims are to determine the feasibility of the methodology and to gather data to inform the conduct of a future, larger trial to investigate if supplementation with vitamin D, in those who are deficient, prior to THR/TKR improves outcomes as measured by PROM scores. DISCUSSION: Previous reports have measured vitamin D levels and correlated this to outcome, but we can find no randomised trial in which researchers investigated the effect of supplementation. The aim of this trial is to determine if vitamin D deficiency is a modifiable risk factor for poor outcome after THR/TKR. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN14533082 . Registered on 3 April 2017.

Original publication

DOI

10.1186/s13063-017-2255-2

Type

Journal article

Journal

Trials

Publication Date

02/11/2017

Volume

18

Keywords

Arthroplasty, Cholecalciferol, Deficiency, Hip, Knee, PROMs, Replacement, THR, TKR, Vitamin D, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Cholecalciferol, Clinical Protocols, Dietary Supplements, England, Feasibility Studies, Humans, Osteoarthritis, Hip, Osteoarthritis, Knee, Patient Reported Outcome Measures, Postoperative Complications, Prospective Studies, Research Design, Risk Factors, Time Factors, Treatment Outcome, Vitamin D, Vitamin D Deficiency