Outcomes After Total Elbow Arthroplasty

Completed

• Conditions: Elbow Disease

• Registration Number: NCT07122570
• Lead Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust

Brief Summary

This study will be an observational study involving patients from Wrightington hospital who underwent implantation of a Latitude elbow prosthesis a minimum of 2 years ago.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2022-07-14
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

All patients who have undergone primary total elbow arthroplasty at Wrightington hospital between January 2014 and June 2018 with a Latitude total elbow prosthesis

Exclusion Criteria

Patients who have undergone TEA with any elbow joint prosthesis other than the Latitude convertible total elbow joint prosthesis Patients whose TEA was not a primary procedure Patient not giving consent for inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival at 2 years post-surgery using a Kaplan-Meier estimate.	survival after surgical intervention	standard statistical methods of Kaplan-Meier

Secondary Outcome Measures

Name	Time	Method
Oxford Shoulder Score	a single time point at 2 years or more after surgical intervention	The Oxford Elbow Score has 12 items (questions) with 5 response options each. Each item response is scored 0 to 4, with 0 representing greater severity.
ELBEX	a single time point at 2 years or more after surgical intervention	a pain section, which uses three 0-10 visual analogue scale scores to record the worst pain experienced from the elbow. also contains a function section, which lists 10 activities of daily living and asks the participant to rate the level of difficulty they experience with that activity using a series of 0-10 scales)
Quick DASH	a single time point at 2 years or more after surgical intervention	QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms
ASES	a single time point at 2 years or more after surgical intervention	divided into three sections: pain, function and satisfaction. The first section contains visual analogical scales (from 0 no pain to 10 worst pain ever) for pain evaluation. The second section contains questions relating to the function of the upper limbs

Trial Locations

Locations (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust; 🇬🇧 Wigan, United Kingdom