VASO - Vitamin D and arthroplasty surgery outcomes
Not Applicable
Completed
- Conditions
- Specialty: Musculoskeletal disorders, Primary sub-specialty: OtherUKCRC code/ Disease: Musculoskeletal/ Other osteopathiesMusculoskeletal DiseasesOsteoarthritis
- Registration Number
- ISRCTN14533082
- Lead Sponsor
- orthumbria Healthcare NHS Foundation Trust
- Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29096686 protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
1. Patients scheduled for primary total hip or knee arthroplasty
2. Aged over 18
3. Presenting at a participating trial site
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Pain and function is measured using the Oxford hip or knee score, collected by written questionnaire at baseline and 6 months<br> 2. Health-related quality of life is measured using the EQ-5D collected by written questionnaire at baseline and 6 months<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Length of hospital stay is collected from medical notes at endline<br> 2. Medical complications including superficial and deep infection are collected from medical notes at endline<br> 3. Readmission rates within 30 days of primary surgery are collected from medical notes at endline<br> 4. Return to theatre rate within 30 days is collected from medical notes at endline<br> 5. Mortality at 90-days is collected from medical notes at endline<br>