Total Elbow ReplacementNCT06760585
Prognostic Factors Associated With Failure of Total Elbow Replacement
An observational study of Total Elbow Replacement, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This observational study aims to evaluate potential prognostic factors for TER failure . The National Joint Registry (NJR) currently contains the largest elbow registry dataset in the world, which has been shown to have high completeness and accuracy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Total Elbow Replacement
- How many people
- 4,073 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2025to 1 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, 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 16 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 2023 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. Contact the study team or a site near you to ask about taking part.
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
Official title: Prognostic Factors Associated With Failure of Total Elbow Replacement: a Protocol for Analysis of National Joint Registry Data
This observational study aims to evaluate potential prognostic factors for TER failure . The National Joint Registry (NJR) currently contains the largest elbow registry dataset in the world, which has been shown to have high completeness and accuracy. In order to incorporate additional potential prognostic factors not captured in the NJR, this study will combine the NJR elbow dataset with the NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data. Understanding prognostic factors is a crucial step for informing the development of strategies aimed at minimising the risk of failure and the necessity for additional surgery, which poses a burden on patients and society.
- Conditions
- Total Elbow Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
The hazard of failure of total elbow replacement
Indicated by the need for revision surgery recorded on the NJR. The NJR's definition of "revision surgery" will be used, which encompasses any operation involving the addition, removal, or modification of one or more components in a joint replacement. This includes debridement, antibiotics, and implant retention (DAIR) with modular exchange procedures.
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
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
- 4,073 participants (estimated)
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
- NCT06760585
- Sponsor's protocol ID
- 7271373
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 14 Jan 2025
- 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, Kearsley-Fleet L, Sergeant JC, Watts AC. Prognostic factors associated with failure of total elbow replacement: a protocol for analysis of National Joint Registry data in England. BMJ Open. 2025 Jul 1;15(7):e098729. doi: 10.1136/bmjopen-2025-098729.
PubMed 40592743
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors Associated With Failure of Total Elbow Replacement: a Protocol for Analysis of National Joint Registry Data
- ClinicalTrials.gov ID
- NCT06760585
- Acronym / sponsor ID
- 7271373
- Conditions
- Total Elbow Replacement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,073 participants (estimated)
- 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
- 15 Jan 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
This observational study aims to evaluate potential prognostic factors for TER failure . The National Joint Registry (NJR) currently contains the largest elbow registry dataset in the world, which has been shown to have high completeness and accuracy. In order to incorporate additional potential prognostic factors not captured in the NJR, this study will combine the NJR elbow dataset with the NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data. Understanding prognostic factors is a crucial step for informing the development of strategies aimed at minimising the risk of failure and the necessity for additional surgery, which poses a burden on patients and society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 16 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 2023 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.
Primary outcome
The hazard of failure of total elbow replacement
Time frame: 11 years
Indicated by the need for revision surgery recorded on the NJR. The NJR's definition of "revision surgery" will be used, which encompasses any operation involving the addition, removal, or modification of one or more components in a joint replacement. This includes debridement, antibiotics, and implant retention (DAIR) with modular exchange procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 40592743Hamoodi Z, Sayers A, Whitehouse MR, Kearsley-Fleet L, Sergeant JC, Watts AC. Prognostic factors associated with failure of total elbow replacement: a protocol for analysis of National Joint Registry data in England. BMJ Open. 2025 Jul 1;15(7):e098729. doi: 10.1136/bmjopen-2025-098729.
- 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
Related trials for Total Elbow Replacement
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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.
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: opening soon, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zaid Hamoodi, MBChB MSc (07533704775, Zaid.hamoodi-2@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hazard of failure of total elbow replacement (time frame: 11 years). 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 NCT06760585, 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 14 Jan 2025.