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The impact of COVID-19 pandemic on the assessment, management and outcomes for patients with common upper limb fractures

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)]

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN91172459
Enrollment
500
Registered
2021-04-26
Start date
2021-04-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The impact of COVID-19 pandemic on patients with wrist or shoulder fracture Injury, Occupational Diseases, Poisoning

Interventions

experiences in accessing health care
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 M
other fracture specific measures (OSS, PRWE)
COVID-19 status (suspected/confirmed)
and satisfaction with treatment. We will also collect data from hospitals on the details of treatment received
re-admissions
complications
secondary interventions
and mortality.

Sponsors

South Tees Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

Exclusion criteria: Patients who lack the mental capacity to understand and complete the study procedures and pathological (other than osteoporotic/fragility related) fractures.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Scotland, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026