Total Elbow ReplacementNCT06355011
Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data
An observational study of Total Elbow Replacement, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Elbow Replacement
- What is being tested?
- Total Elbow Replacement
- Type of treatment
- Medical device
- How many people
- 3,891 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2024to 2 Apr 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a primary total elbow replacement in England on the National Joint Registry (NJR)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre
Manchester, M13 9PT
About this study
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.
- Conditions
- Total Elbow Replacement
- Being tested
- Total Elbow Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Elbow ReplacementDevice
Total elbow replacement is a procedure that involves replacing the elbow joint with an implanted device to alleviate pain and improve function.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Yearly (1 year) incidence for a 10 year period
Secondary outcomes (5)
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.
Measured: 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
Measured: Up to 10 years period
Post-operative duration of stay
The number of days from the time of surgery until discharge from the hospital
Measured: Up to 10 years period
Surgeon volume
Number of TERs performed by a surgeon per year by surgeons in England
Measured: 10 year (2012 to 2022)
Hospital volume
Number of TERs performed by a hospital per year by surgeons in England
Measured: 10 year (2012 to 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Mar 2024
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Elbow ReplacementStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,891 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The National Joint Registry, The Royal College of Surgeons of England, John Charnley Trust, University of Bristol
- Responsible party
- Principal investigator, Zaid Hamoodi, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355011
- Sponsor's protocol ID
- 7016194
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Hamoodi Z, Sayers A, Whitehouse MR, Rangan A, Kearsley-Fleet L, Sergeant JC, Watts AC. Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data. J Orthop Surg Res. 2024 Aug 30;19(1):526. doi: 10.1186/s13018-024-04903-9.
PubMed 39215301
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data
- ClinicalTrials.gov ID
- NCT06355011
- Acronym / sponsor ID
- 7016194
- Conditions
- Total Elbow Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,891 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The National Joint Registry, The Royal College of Surgeons of England, John Charnley Trust, University of Bristol
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a primary total elbow replacement in England on the National Joint Registry (NJR)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Elbow ReplacementTotal elbow replacement is a procedure that involves replacing the elbow joint with an implanted device to alleviate pain and improve function. | Device | – |
Primary outcome
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.
5 secondary outcomes
Serious adverse events or re-admissions
Time frame: 30 and 90 days after the index TER
Duration of elective wait
Time frame: Up to 10 years period
Post-operative duration of stay
Time frame: Up to 10 years period
Surgeon volume
Time frame: 10 year (2012 to 2022)
Hospital volume
Time frame: 10 year (2012 to 2022)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 39215301Hamoodi Z, Sayers A, Whitehouse MR, Rangan A, Kearsley-Fleet L, Sergeant JC, Watts AC. Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data. J Orthop Surg Res. 2024 Aug 30;19(1):526. doi: 10.1186/s13018-024-04903-9.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Elbow Replacement, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of total elbow replacement (TER) in England (time frame: Yearly (1 year) incidence for a 10 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.