Clinical trial NCT06355011: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data
Official title: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Elbow Replacement
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The National Joint Registry
name: The Royal College of Surgeons of England
name: John Charnley Trust
name: University of Bristol
First posted: 2024-04-09
Enrollment: 3891
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a primary total elbow replacement in England on the National Joint Registry (NJR)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of total elbow replacement (TER) in England
timeFrame: Yearly (1 year) incidence for a 10 year period
Secondary outcomes:
measure: Serious adverse events or re-admissions
timeFrame: 30 and 90 days after the index TER
measure: Duration of elective wait
timeFrame: Up to 10 years period
measure: Post-operative duration of stay
timeFrame: Up to 10 years period
measure: Surgeon volume
timeFrame: 10 year (2012 to 2022)
measure: Hospital volume
timeFrame: 10 year (2012 to 2022)
Other outcomes:
measure: Patient characteristics (Age)
timeFrame: 10 year (2012 to 2022)
measure: Body mass index
timeFrame: 10 year (2012 to 2022)
measure: Hand dominance
timeFrame: 10 year (2012 to 2022)
measure: American Society of Anaesthesiologists (ASA) grade
timeFrame: 10 year (2012 to 2022)
measure: Indication for total elbow replacement
timeFrame: 10 year (2012 to 2022)
measure: Socioeconomic status
timeFrame: 10 year (2012 to 2022)
measure: Ethnicity
timeFrame: 10 year (2012 to 2022)
measure: Co-morbidities
timeFrame: 10 year (2012 to 2022)
measure: Charlson Comorbidity Index
timeFrame: 10 year (2012 to 2022)
measure: Implant classification
timeFrame: 10 year (2012 to 2022)
measure: Fixation type
timeFrame: 10 year (2012 to 2022)
measure: Implant type
timeFrame: 10 year (2012 to 2022)
measure: If radial head replacement was used
timeFrame: 10 year (2012 to 2022)
measure: Grade of primary surgeon
timeFrame: 10 year (2012 to 2022)
measure: Funding
timeFrame: 10 year (2012 to 2022)
measure: Elective admission type
timeFrame: 10 year (2012 to 2022)
Locations:
city: Manchester
country: United Kingdom
facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre
Study officials:
References: