Prognostic Factors Associated With Failure of Total Elbow Replacement

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Elbow Replacement

• Study Type: Observational
• Enrollment (Estimated): 4073

Contacts and Locations

• Study Contact: Name: Zaid Hamoodi, MBChB MSc; Phone Number: 07533704775; Email: Zaid.hamoodi-2@postgrad.manchester.ac.uk

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

Eligibility Criteria

• Ages Eligible for Study: Child; 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 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	11 years

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: University of Bristol; The Royal College of Surgeons of England; The National Joint Registry; John Charnley Trust

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 7271373

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