CClinicalTrials.gg
Not yet recruitingNCT06760585Updated Jan 14, 2025

Prognostic Factors Associated With Failure of Total Elbow Replacement

An observational study in Total Elbow Replacement, sponsored by University of Manchester. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by University of Manchester · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,073
Ages
16 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Total Elbow Replacement
03

In context

Lead sponsor

University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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)

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,073 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 11 years

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Study locations

1 site
  • Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre
    Manchester, M13 9PT, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06760585
Lead sponsor
University of Manchester
Collaborators
The National Joint Registry, The Royal College of Surgeons of England, John Charnley Trust, University of Bristol
Responsible party
Zaid Hamoodi (National Joint Registry research fellow and PhD Student, University of Manchester) — Principal investigator
First posted
Jan 7, 2025
Start date
Jan 15, 2025 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Jan 14, 2025

Study contacts

Zaid Hamoodi, MBChB MSc
Contact
Zaid.hamoodi-2@postgrad.manchester.ac.uk
07533704775

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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