Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data

Completed

• Conditions: Total Elbow Replacement

• Registration Number: NCT06355011
• Lead Sponsor: University of Manchester

Brief Summary

The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:

* Who are receiving primary total elbow replacement surgery?

* Where and by whom is the total elbow replacement surgery is being performed?

* What the current surgical practices for total elbow replacement?

Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-19
• Status Verified: 2024-04
• Primary Completion: 2024-04-02
• Study Completion: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3891

Inclusion Criteria

• All patients aged 18 to 100 years old with a primary TER on the National Joint Registry (NJR) elbow dataset from the start of data collection on the 1st of April 2012 to the 31st of December 2022 will be included.

Exclusion Criteria

• Patients are excluded if they did not consent for their data to be used for research purposes, if it is impossible to trace them after surgery, if their ID numbers are invalid, or if the surgery was not performed in England.
• Unconfirmed procedures and procedures with inconsistent operative patterns (i.e. a sequence of operations where the primary operation is not the first operation in the sequence or where there are multiple primary operations recorded for the same joint) will be excluded from the analyses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of total elbow replacement (TER) in England	Yearly (1 year) incidence for a 10 year period	The number and age-sex standardised rate of TER for different sexes, ethnicities, and socioeconomic backgrounds.

Secondary Outcome Measures

Name	Time	Method
Post-operative duration of stay	Up to 10 years period	The number of days from the time of surgery until discharge from the hospital
Serious adverse events or re-admissions	30 and 90 days after the index TER	Serious adverse events will be defined as any severe medical complications leading to hospital admission, including pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all-cause death.
Duration of elective wait	Up to 10 years period	The number of days between the decision for total elbow replacement and the actual day of surgery
Surgeon volume	10 year (2012 to 2022)	Number of TERs performed by a surgeon per year by surgeons in England
Hospital volume	10 year (2012 to 2022)	Number of TERs performed by a hospital per year by surgeons in England

Trial Locations

Locations (1)

Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre; 🇬🇧 Manchester, United Kingdom