Elbow DiseaseNCT07122570
Outcomes After Total Elbow Arthroplasty
An observational study of Elbow Disease, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Disease
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2020to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who had a Latitude elbow replacement for elbow arthritis
Who may be able to join
- All patients who have undergone primary total elbow arthroplasty at Wrightington hospital between January 2014 and June 2018 with a Latitude total elbow prosthesis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN6 9EP
About this study
Official title: Outcomes After Total Elbow Arthroplasty Using the Latitude Elbow Prosthesis: A 2-year Observational Study
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.
- Conditions
- Elbow Disease
- Keywords
- arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival at 2 years post-surgery using a Kaplan-Meier estimate.
standard statistical methods of Kaplan-Meier
Measured: survival after surgical intervention
Secondary outcomes (4)
Oxford Shoulder Score
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.
Measured: a single time point at 2 years or more after surgical intervention
ELBEX
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)
Measured: a single time point at 2 years or more after surgical intervention
Quick DASH
QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms
Measured: a single time point at 2 years or more after surgical intervention
ASES
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
Measured: a single time point at 2 years or more after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Oct 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian A Trail, Principal investigator, Wrightington, Wigan & Leigh Teaching Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122570
- Sponsor's protocol ID
- Latitude
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Total Elbow Arthroplasty Using the Latitude Elbow Prosthesis: A 2-year Observational Study
- ClinicalTrials.gov ID
- NCT07122570
- Acronym / sponsor ID
- Latitude
- Conditions
- Elbow Disease
- Keywords
- arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who had a Latitude elbow replacement for elbow arthritis
Key inclusion criteria (1 listed)
- All patients who have undergone primary total elbow arthroplasty at Wrightington hospital between January 2014 and June 2018 with a Latitude total elbow prosthesis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant survival at 2 years post-surgery using a Kaplan-Meier estimate.
Time frame: survival after surgical intervention
standard statistical methods of Kaplan-Meier
4 secondary outcomes
Oxford Shoulder Score
Time frame: a single time point at 2 years or more after surgical intervention
ELBEX
Time frame: a single time point at 2 years or more after surgical intervention
Quick DASH
Time frame: a single time point at 2 years or more after surgical intervention
ASES
Time frame: a single time point at 2 years or more after surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Related trials for Elbow Disease
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian A Trail principal investigator
Wrightington, Wigan & Leigh Teaching Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Disease, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival at 2 years post-surgery using a Kaplan-Meier estimate. (time frame: survival after surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.