FAMOUS-C19
Research type
Research Study
Full title
The impact of COVID-19 pandemic on the assessment, management and outcomes for patients with common upper Limb fractures in the UK: a multi-centre observational cohort study. [FAMOUS-C19 (Fracture Assessment, Management and Outcomes in Upper limb Study during Covid-19)]
IRAS ID
292033
Contact name
Amar Rangan
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 5 months, 2 days
Research summary
The study aim is to investigate the impact of COVID-19 pandemic on wrist (distal radius) and shoulder (proximal humerus) fracture management within the UK, and to quantify any impact on patient outcomes. This is a UK-wide multi-centre observational study, including remote follow up with patient questionnaires. Up to 500 adult patients who have previously presented pre-pandemic (1 December 2019 to 14 March 2020) and during the prevalent phase of UK COVID-19 pandemic (15 March to 30 June 2020) to orthopaedic services with fractures of the wrist and shoulder will be approached to consider participating in the study.
For patients who consent, we will collect baseline demographic data, underlying health conditions, fracture details, and preferred vs provided treatment. Follow up patient questionnaires at 12 and 24 months post injury will include validated items to assess outcomes, and will include: EQ-5D-5L; other fracture specific measures (OSS, PRWE); COVID-19 status (suspected/confirmed); experiences in accessing health care; and satisfaction with treatment. We will also collect data from hospitals on the details of treatment received; re-admissions; complications; secondary interventions; and mortality.
This study has been designed to capture key information on changes in management of adults with common upper extremity fractures within orthopaedic trauma services in the UK during the COVID-19 pandemic. Patients with these fractures and their outcomes will be assessed to improve our understanding of the impact of the COVID-19 pandemic on fracture care. The results of this study are also likely to more generally help inform other clinical trials that have been suspended due to COVID-19, about the potential impact of the pandemic on trial participants. Our established and effective clinical recruiting networks for trauma and orthopaedic trials, including the trainee research collaborative CORNET (Collaborative Orthopaedic Research Network) will help deliver the project within the specified timescale.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0014
Date of REC Opinion
7 Jan 2021
REC opinion
Favourable Opinion