Prognostic Factors Associated With Failure of Total Elbow Replacement

NCT ID: NCT06760585

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4073 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Elbow Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The National Joint Registry

UNKNOWN

Sponsor Role collaborator

The Royal College of Surgeons of England

OTHER

Sponsor Role collaborator

John Charnley Trust

UNKNOWN

Sponsor Role collaborator

University of Bristol

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zaid Hamoodi

National Joint Registry research fellow and PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zaid Hamoodi, MBChB MSc

Role: CONTACT

07533704775

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40592743 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7271373

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Total Ankle Replacement Versus Arthrodesis Trial
NCT02128555 ACTIVE_NOT_RECRUITING NA