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Completed

NCT Number: NCT07122570

Outcomes After Total Elbow Arthroplasty

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.

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Key information

Conditions

Elbow Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implant survival at 2 years post-surgery using a Kaplan-Meier estimate.

    Time frame: survival after surgical intervention

    standard statistical methods of Kaplan-Meier

Secondary outcomes

  1. Oxford Shoulder Score

    Time frame: 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.

  2. ELBEX

    Time frame: 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)

  3. Quick DASH

    Time frame: 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

  4. ASES

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wrightington, Wigan and Leigh NHS Foundation Trust

Other

Registry information

Official study title

Outcomes After Total Elbow Arthroplasty Using the Latitude Elbow Prosthesis: A 2-year Observational Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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