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

April 2, 2024 updated by: Zaid Hamoodi, University of Manchester

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3891

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Yearly (1 year) incidence for a 10 year period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 and 90 days after the index TER
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
Up to 10 years period
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
Up to 10 years period
Surgeon volume
Time Frame: 10 year (2012 to 2022)
Number of TERs performed by a surgeon per year by surgeons in England
10 year (2012 to 2022)
Hospital volume
Time Frame: 10 year (2012 to 2022)
Number of TERs performed by a hospital per year by surgeons in England
10 year (2012 to 2022)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient characteristics (Age)
Time Frame: 10 year (2012 to 2022)
Age in years
10 year (2012 to 2022)
Body mass index
Time Frame: 10 year (2012 to 2022)
BMI measured in in kg/m^2
10 year (2012 to 2022)
Hand dominance
Time Frame: 10 year (2012 to 2022)
Dominant non-dominant hand
10 year (2012 to 2022)
American Society of Anaesthesiologists (ASA) grade
Time Frame: 10 year (2012 to 2022)
Grades 1-5
10 year (2012 to 2022)
Indication for total elbow replacement
Time Frame: 10 year (2012 to 2022)
Categories: Acute trauma/inflammatory/ Trauma sequelae/Osteoarthritis/ Other
10 year (2012 to 2022)
Socioeconomic status
Time Frame: 10 year (2012 to 2022)
Categorical: Indices of multiple deprivation quintiles (2015 version)
10 year (2012 to 2022)
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
10 year (2012 to 2022)
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
10 year (2012 to 2022)
Charlson Comorbidity Index
Time Frame: 10 year (2012 to 2022)
Original Charlson Comorbidity Index
10 year (2012 to 2022)
Implant classification
Time Frame: 10 year (2012 to 2022)
Categorical: Linked/ Unlinked
10 year (2012 to 2022)
Fixation type
Time Frame: 10 year (2012 to 2022)
Categorical: Cemented/ Uncemented
10 year (2012 to 2022)
Implant type
Time Frame: 10 year (2012 to 2022)
Categorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP
10 year (2012 to 2022)
If radial head replacement was used
Time Frame: 10 year (2012 to 2022)
Categorical: Yes/No
10 year (2012 to 2022)
Grade of primary surgeon
Time Frame: 10 year (2012 to 2022)
Categorical: Consultant/Other
10 year (2012 to 2022)
Funding
Time Frame: 10 year (2012 to 2022)
Categorical: National Health Services (NHS) /Independent sector
10 year (2012 to 2022)
Elective admission type
Time Frame: 10 year (2012 to 2022)
Categorical: General admission/ Day case admission
10 year (2012 to 2022)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bristol
The Royal College of Surgeons of England
The National Joint Registry
John Charnley Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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