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Completed

NCT Number: NCT06355011

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.

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Key information

Conditions

Total Elbow Replacement

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre

Manchester, M13 9PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Elbow Replacement

Device

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

Primary outcomes

  1. The incidence of total elbow replacement (TER) in England

    Time frame: 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 outcomes

  1. Serious adverse events or re-admissions

    Time frame: 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.

  2. Duration of elective wait

    Time frame: Up to 10 years period

    The number of days between the decision for total elbow replacement and the actual day of surgery

  3. Post-operative duration of stay

    Time frame: Up to 10 years period

    The number of days from the time of surgery until discharge from the hospital

  4. Surgeon volume

    Time frame: 10 year (2012 to 2022)

    Number of TERs performed by a surgeon per year by surgeons in England

  5. Hospital volume

    Time frame: 10 year (2012 to 2022)

    Number of TERs performed by a hospital per year by surgeons in England

Other outcomes

  1. Patient characteristics (Age)

    Time frame: 10 year (2012 to 2022)

    Age in years

  2. Body mass index

    Time frame: 10 year (2012 to 2022)

    BMI measured in in kg/m^2

  3. Hand dominance

    Time frame: 10 year (2012 to 2022)

    Dominant non-dominant hand

  4. American Society of Anaesthesiologists (ASA) grade

    Time frame: 10 year (2012 to 2022)

    Grades 1-5

  5. Indication for total elbow replacement

    Time frame: 10 year (2012 to 2022)

    Categories: Acute trauma/inflammatory/ Trauma sequelae/Osteoarthritis/ Other

  6. Socioeconomic status

    Time frame: 10 year (2012 to 2022)

    Categorical: Indices of multiple deprivation quintiles (2015 version)

  7. Ethnicity

    Time frame: 10 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

  8. Co-morbidities

    Time frame: 10 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

  9. Charlson Comorbidity Index

    Time frame: 10 year (2012 to 2022)

    Original Charlson Comorbidity Index

  10. Implant classification

    Time frame: 10 year (2012 to 2022)

    Categorical: Linked/ Unlinked

  11. Fixation type

    Time frame: 10 year (2012 to 2022)

    Categorical: Cemented/ Uncemented

  12. Implant type

    Time frame: 10 year (2012 to 2022)

    Categorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP

  13. If radial head replacement was used

    Time frame: 10 year (2012 to 2022)

    Categorical: Yes/No

  14. Grade of primary surgeon

    Time frame: 10 year (2012 to 2022)

    Categorical: Consultant/Other

  15. Funding

    Time frame: 10 year (2012 to 2022)

    Categorical: National Health Services (NHS) /Independent sector

  16. Elective admission type

    Time frame: 10 year (2012 to 2022)

    Categorical: General admission/ Day case admission

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • John Charnley Trust
  • The National Joint Registry
  • The Royal College of Surgeons of England
  • University of Bristol

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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