The impact of COVID-19 pandemic on the assessment, management and outcomes for patients with common upper limb fractures
| ISRCTN | ISRCTN91172459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91172459 |
| IRAS number | 292033 |
| Secondary identifying numbers | CPMS 48040, IRAS 292033 |
- Submission date
- 19/03/2021
- Registration date
- 26/04/2021
- Last edited
- 15/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
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 investigate the impact on patient recovery.
Who can participate?
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.
What does the study involve?
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 questionnaires to assess outcomes. We will also collect data from hospitals on the details of treatment received; re-admissions; complications; secondary interventions; and mortality.
What are the possible benefits and risks of participating?
The study will improve our understanding of the impact of the Covid-19 pandemic on upper limb fracture care. The results of this study are likely to generally help inform other research studies that have been suspended due to Covid-19, about the potential impact of the pandemic on participants of those studies and the impact on patient outcomes due to changes in treatment pathways during the pandemic. It may also help us design appropriate care pathways for patients with upper limb fractures if services are affected in the future as a result of a pandemic.
There are no identified disadvantages or risks from taking part in this research study due to the observational nature.
Where is the study run from?
The James Cook University Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2021 to May 2023
Who is funding the study?
AO UK & I (UK)
Who is the main contact?
Dr Lucksy Kottam, lucksy.kottam@nhs.net
Prof. Amar Rangan, amar.rangan@york.ac.uk
Contact information
Scientific
Room 12B04, STRIVE Academic Centre
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
 ORCID ID |
0000-0002-7976-2416 |
|---|---|
| Phone | +44 (0)1642854814 |
| lucksy.kottam@nhs.net |
Scientific
Room 12B04, STRIVE Academic Centre
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| ORCID ID |
0000-0002-5452-8578 |
|---|---|
| Phone | +44 (0)1642854144 |
| amar.rangan@york.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN91172459_PIS_V2.0_15Jan20.docx |
| Scientific 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)] |
| Study acronym | FAMOUS-C19 |
| Study objectives | 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 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. |
| Ethics approval(s) | Approved 07/01/2021 East Midlands - Derby Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048276; derby.rec@hra.nhs.uk), ref: 21/EM/0014 |
| Health condition(s) or problem(s) studied | The impact of COVID-19 pandemic on patients with wrist or shoulder fracture |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Patient-reported outcomes in the management of upper extremity fractures: 1. OSS for Proximal Humeral Fractures at baseline and 24 months 2. PRWE for Wrist fractures at baseline and 24 months |
| Secondary outcome measures | Collected at baseline: 1. Demographic data, underlying health conditions, fracture details, preferred vs provided treatment details. Collected at 12 and 24 months: 2. Quality of life (EQ-5D-5L) 3. Fracture specific measures (OSS/PRWE) 4. COVID-19 status (suspected/confirmed) measured using ‘Non validated Patient Reported Outcome Questionnaire’ 5. Experiences in accessing health care measured using ‘Numeric Rating Scale’ 6. Satisfaction with treatment measured using – ‘Numeric Rating Scale’ 7. Loss of productivity (i.e. days off work; change in work status) measured using ‘Non validated Patient Reported Outcome Questionnaire’ Collected at hospital follow-up 24 months using patient records: 8. Treatment received 9. Re-admissions 10. Complications 11. Secondary interventions 12. Mortality |
| Overall study start date | 07/01/2021 |
| Completion date | 02/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key inclusion criteria | Adult patients who have presented to the orthopaedic trauma service within participating NHS hospitals with radiologically confirmed fractures of the proximal humerus or distal radius between 1 December 2019 to 14 March 2020 (Pre-pandemic phase) and between 15 March 2020 and 30 June 2020 (Pandemic phase). |
| Key exclusion criteria | Patients who lack the mental capacity to understand and complete the study procedures and pathological (other than osteoporotic/fragility related) fractures. |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- United States of America
Study participating centres
Marton Road
Middlesbrough
Cleveland
TS4 3BW
United Kingdom
Hardwick
Stockton on Tees
TS19 8PE
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Kemptown
Brighton
BN2 1ES
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Whitechapel Road
Whitechapel
London
E1 1BB
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
Frimley
GU16 7UJ
United Kingdom
North road
Durham
DH1 5TW
United Kingdom
Kadoorie Centre
Level 3
Headley Way
Oxford
OX3 9DU
United Kingdom
Lower Ln
Liverpool
L9 7AL
United Kingdom
Top Road
Chesterfield
S44 5BL
United Kingdom
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Leicester
LE1 5WW
United Kingdom
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Colney Lane
Norwich
NR4 7UY
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
North Shields
NE29 8NH
United States of America
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Gayton Road
King’s Lynn
PE30 4ET
United Kingdom
Heath Road
Ipswich
IP4 5PD
United Kingdom
Chelmsford
CM1 7ET
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Hospital/treatment centre
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 (0)1642 854089 |
|---|---|
| joe.millar@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 02/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Anonymised aggregate data will be held securely at South Tees Hospitals NHS Foundation Trust and can be made available on appropriate request with clearly stated purpose. They could write to Prof Amar Rangan via email amar.rangan@york.ac.uk with the request. Data will be available for 5 years from study completion. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.0 | 15/01/2020 | 26/04/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN91172459_PIS_V2.0_15Jan20.docx
- Uploaded 26/04/2021
Editorial Notes
15/12/2022: The contact confirmed the record is up to date.
25/07/2022: The overall trial end date has been changed from 30/06/2022 to 02/05/2023 and the plain English summary updated accordingly.
14/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 02/05/2023 to 30/06/2022.
2. The plain English summary was updated to reflect these changes.
26/04/2021: The participant information sheet has been uploaded.
19/03/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
