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

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.

Study Overview

• Status: Completed
• Conditions: Total Elbow Replacement
• Intervention / Treatment: Device: Total Elbow Replacement

• Study Type: Observational
• Enrollment (Actual): 3891

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PT
    • Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a primary total elbow replacement in England on the National Joint Registry (NJR)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events or re-admissions	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.	30 and 90 days after the index TER
Duration of elective wait	The number of days between the decision for total elbow replacement and the actual day of surgery	Up to 10 years period
Post-operative duration of stay	The number of days from the time of surgery until discharge from the hospital	Up to 10 years period
Surgeon volume	Number of TERs performed by a surgeon per year by surgeons in England	10 year (2012 to 2022)
Hospital volume	Number of TERs performed by a hospital per year by surgeons in England	10 year (2012 to 2022)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics (Age)	Age in years	10 year (2012 to 2022)
Body mass index	BMI measured in in kg/m^2	10 year (2012 to 2022)
Hand dominance	Dominant non-dominant hand	10 year (2012 to 2022)
American Society of Anaesthesiologists (ASA) grade	Grades 1-5	10 year (2012 to 2022)
Indication for total elbow replacement	Categories: Acute trauma/inflammatory/ Trauma sequelae/Osteoarthritis/ Other	10 year (2012 to 2022)
Socioeconomic status	Categorical: Indices of multiple deprivation quintiles (2015 version)	10 year (2012 to 2022)
Ethnicity	Categorical: Asian, Asian British, or Asian Welsh /Black, Black British, Black Welsh, Caribbean or African/White/Mixed or Multiple ethnic groups/Other ethnic group	10 year (2012 to 2022)
Co-morbidities	Categorical: Acute MI /CHF / PVD/ Cerebrovascular Disease / Dementia/ COPD/ Rheumatoid Disease/ Peptic Ulcer/ Mild liver disease/ Diabetes/ Diabetes + Complications/ Hemiplegia or Paraplegia/ Renal disease/ Cancer/ Moderate/Severe liver disease/ Metastatic Cancer/ AIDS/ Depression/ Anxiety/ Osteoporosis	10 year (2012 to 2022)
Charlson Comorbidity Index	Original Charlson Comorbidity Index	10 year (2012 to 2022)
Implant classification	Categorical: Linked/ Unlinked	10 year (2012 to 2022)
Fixation type	Categorical: Cemented/ Uncemented	10 year (2012 to 2022)
Implant type	Categorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP	10 year (2012 to 2022)
If radial head replacement was used	Categorical: Yes/No	10 year (2012 to 2022)
Grade of primary surgeon	Categorical: Consultant/Other	10 year (2012 to 2022)
Funding	Categorical: National Health Services (NHS) /Independent sector	10 year (2012 to 2022)
Elective admission type	Categorical: General admission/ Day case admission	10 year (2012 to 2022)

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: University of Bristol; The Royal College of Surgeons of England; The National Joint Registry; John Charnley Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 7016194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The National Joint Registry (NJR) elbow data can be requested for research purposes through an application to the NJR research committee. Researchers do not have the rights to share the data directly

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No