VASO - Vitamin D and arthroplasty surgery outcomes

ISRCTN	ISRCTN14533082
DOI	https://doi.org/10.1186/ISRCTN14533082
Secondary identifying numbers	33969

Submission date: 27/03/2017
Registration date: 03/04/2017
Last edited: 21/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that having enough vitamin D can help prevent many diseases, such as heart disease, bone diseases and cancer. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. 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 Vitamin D levels. There is evidence that patients who are having knee or hip replacement surgery who have low vitamin D levels could have a poorer outcome and a longer stay in hospital. This study is looking at whether checking patient's Vitamin D levels before they have surgery can help 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, as these deficient patients could start taking supplements to correct the deficiency before surgery until six months afterwards in order to improve outcomes.

Who can participate?
Adults who are scheduled to have hip or knee replacement surgery

What does the study involve?
Patients have their vitamin D levels measured at the beginning of the study. Those who are found to have low vitamin D levels are then randomly allocated into one of two groups. Those in the first group receive Vitamin D supplementation before surgery until six months after surgery, and those in the second group receive no vitamin D supplements. Participants in both groups are followed up using questionnaires six months after their surgery and have their medical records reviewed in order to assess how well they have recovered.

What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the study, as currently it is not known whether screening and then treating Vitamin D deficiency before surgery is beneficial. However, it is hoped that the information from the study will help future patients having hip or knee replacement. There are no notable risks involved with participating.

Where is the study run from?
Five NHS hospitals in the north of England (UK)

When is the study starting and how long is it expected to run for?
January 2016 to November 2018

Who is funding the study?
Orthopaedic Research UK (UK)

Who is the main contact?
Dr Rory Morrison
rorymorrison@nhs.net

Study website

Contact information

Mr Rory Morrison
Scientific

North Tyneside General Hospital
Rake Lane
North Shields
NE63 9JJ
United Kingdom

Phone	+44 (0)1670 564132
Email	rorymorrison@nhs.net

Study information

Study design	Randomised; Interventional; Design type: Treatment, Screening, Drug
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A prospective, randomised-controlled feasibility study investigating the benefit of screening for Vitamin D deficiency in a pre-operative elective arthroplasty setting
Study acronym	VASO
Study hypothesis	A vitamin D level below normal (hypovitaminosis D or Vitamin D insufficiency/deficiency) is linked to a poorer outcome whereas a normal level is linked to an improved outcome following primary, elective hip or knee arthroplasty.
Ethics approval(s)	Yorkshire and The Humber - Bradford Leeds Research Ethics Committee, 13/03/2017, ref: 17/YH/0067
Condition	Specialty: Musculoskeletal disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Musculoskeletal/ Other osteopathies
Intervention	All patients in this feasibility trial will have their Vitamin D level checked before surgery, on the day of surgery and at 6 months after surgery. Those patients who, before their operation, are found to have a Vitamin D level below normal will be randomised to one of two groups. Intervention group: Participants receive Vitamin D supplementation each day before surgery and for 6 months following surgery. The dosage of Vitamin D given is dependent on the patient’s levels. Deficiency (<25nmol/L): 20,000 units orally twice per week for 8 weeks then 1,600 units orally daily until 6 months following surgery Insufficiency (25-49nmol/L): 1,600 units orally daily until 6 months following surgery. Vitamin D levels are rechecked day of surgery and at 6-months following surgery Control group: Participants receive no supplementation. Participants are followed up six months post-surgery via questionnaires and medical record review.
Intervention type	Supplement
Primary outcome measure	1. Pain and function is measured using the Oxford hip or knee score, collected by written questionnaire at baseline and 6 months 2. Health-related quality of life is measured using the EQ-5D collected by written questionnaire at baseline and 6 months
Secondary outcome measures	1. Length of hospital stay is collected from medical notes at endline 2. Medical complications including superficial and deep infection are collected from medical notes at endline 3. Readmission rates within 30 days of primary surgery are collected from medical notes at endline 4. Return to theatre rate within 30 days is collected from medical notes at endline 5. Mortality at 90-days is collected from medical notes at endline
Overall study start date	03/01/2016
Overall study end date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 100; UK Sample Size: 100
Total final enrolment	102
Participant inclusion criteria	1. Patients scheduled for primary total hip or knee arthroplasty 2. Aged over 18 3. Presenting at a participating trial site
Participant exclusion criteria	1. Lack of mental capacity to understand/comply with study procedures 2. Revision surgery 3. Known contraindication to Vitamin D treatment, e.g. previous diagnosis of sarcoidosis, primary hyperparathyroidism or other hypercalcaemic disorders, allergy 4. Renal impairment with eGFR <30 mL/minute 5. Already taking a Vitamin D supplement
Recruitment start date	04/05/2017
Recruitment end date	30/06/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Wansbeck General Hospital

Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

North Tyneside General Hospital

Rake Lane
North Shields
NE29 8NH
United Kingdom

Hexham General Hospital

Corbridge Road
Hexham
NE46 1QJ
United Kingdom

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

The Friarage Hospital

Northallerton
DL6 1JG
United Kingdom

Sponsor information

Northumbria Healthcare NHS Foundation Trust
Hospital/treatment centre

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
England
United Kingdom

Phone	+44 (0)191 293 4087
Email	ResearchAndDevelopment@northumbria-healthcare.nhs.uk
"ROR"	https://ror.org/01gfeyd95

Funders

Funder type

Charity

Orthopaedic Research UK
Private sector organisation / For-profit companies (industry)

Location: United Kingdom

Results and Publications

Intention to publish date	30/11/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a peer reviewed journal and presentation at relevant scientific meetings.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to a lack of participant consent.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	02/11/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

21/02/2022: IPD sharing statement added.
10/01/2022: Total final enrolment added.
06/11/2017: Publication reference added.
08/05/2017: The recruitment start date has been updated from 24/04/2017 to 04/05/2017.
18/04/2017: The recruitment start date has been updated from 16/04/2017 to 24/04/2017.