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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06355011
Enrollment
3891
Registered
2024-04-09
Start date
2024-03-01
Completion date
2024-04-02
Last updated
2024-04-09

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

Conditions

Total Elbow Replacement

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.

Interventions

DEVICETotal Elbow Replacement

Total elbow replacement is a procedure that involves replacing the elbow joint with an implanted device to alleviate pain and improve function.

Sponsors

The National Joint Registry
CollaboratorUNKNOWN
The Royal College of Surgeons of England
CollaboratorOTHER
John Charnley Trust
CollaboratorUNKNOWN
University of Bristol
CollaboratorOTHER
University of Manchester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of total elbow replacement (TER) in EnglandYearly (1 year) incidence for a 10 year periodThe number and age-sex standardised rate of TER for different sexes, ethnicities, and socioeconomic backgrounds.

Secondary

MeasureTime frameDescription
Serious adverse events or re-admissions30 and 90 days after the index TERSerious 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 waitUp to 10 years periodThe number of days between the decision for total elbow replacement and the actual day of surgery
Post-operative duration of stayUp to 10 years periodThe number of days from the time of surgery until discharge from the hospital
Surgeon volume10 year (2012 to 2022)Number of TERs performed by a surgeon per year by surgeons in England
Hospital volume10 year (2012 to 2022)Number of TERs performed by a hospital per year by surgeons in England

Other

MeasureTime frameDescription
Indication for total elbow replacement10 year (2012 to 2022)Categories: Acute trauma/inflammatory/ Trauma sequelae/Osteoarthritis/ Other
Socioeconomic status10 year (2012 to 2022)Categorical: Indices of multiple deprivation quintiles (2015 version)
Ethnicity10 year (2012 to 2022)Categorical: Asian, Asian British, or Asian Welsh /Black, Black British, Black Welsh, Caribbean or African/White/Mixed or Multiple ethnic groups/Other ethnic group
Co-morbidities10 year (2012 to 2022)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
Charlson Comorbidity Index10 year (2012 to 2022)Original Charlson Comorbidity Index
If radial head replacement was used10 year (2012 to 2022)Categorical: Yes/No
Fixation type10 year (2012 to 2022)Categorical: Cemented/ Uncemented
Implant type10 year (2012 to 2022)Categorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP
Funding10 year (2012 to 2022)Categorical: National Health Services (NHS) /Independent sector
Elective admission type10 year (2012 to 2022)Categorical: General admission/ Day case admission
Implant classification10 year (2012 to 2022)Categorical: Linked/ Unlinked
Grade of primary surgeon10 year (2012 to 2022)Categorical: Consultant/Other
Patient characteristics (Age)10 year (2012 to 2022)Age in years
Body mass index10 year (2012 to 2022)BMI measured in in kg/m\^2
Hand dominance10 year (2012 to 2022)Dominant non-dominant hand
American Society of Anaesthesiologists (ASA) grade10 year (2012 to 2022)Grades 1-5

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026