NCT07122570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

July 14, 2022

Last Update Submit

August 12, 2025

Conditions

Elbow Disease

Keywords

arthroplasty

Outcome Measures

Primary Outcomes (1)

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

    standard statistical methods of Kaplan-Meier

    survival after surgical intervention

Secondary Outcomes (4)

  • Oxford Shoulder Score

    a single time point at 2 years or more after surgical intervention

  • ELBEX

    a single time point at 2 years or more after surgical intervention

  • Quick DASH

    a single time point at 2 years or more after surgical intervention

  • ASES

    a single time point at 2 years or more after surgical intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who had a Latitude elbow replacement for elbow arthritis

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Location

Study Officials

  • Ian A Trail

    Wrightington, Wigan & Leigh Teaching Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

August 14, 2025

Study Start

October 15, 2020

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations

GB(1)