Elbow Arthroplasty and Patient Reported Post-operative Activities (EAA)

August 6, 2025 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Patients who underwent Total elbow replacement from and after 2010 with a minimum of 6 months at a single institution will be studied retrospectively. The data required for the study will be collected prospectively. Patient demographic data will be collected through the Information team and electronic patient record. Surveys will include questions about whether they recalled the activities that were not recommended by the surgeons, oxford elbow scores and the type of activities they currently perform. Patients will be contacted by telephone after initial screening against inclusion and exclusion criteria, and subsequent questionnaires will be sent through post or by email, whichever the patient prefers. Patients who do not respond to the postal or email questionnaire will be contacted again by telephone.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Total elbow arthroplasty is an increasingly common treatment for patients with destructive elbow pathology like osteoarthritis, rheumatoid arthritis, trauma and trauma sequelae. However, the revision rates and complication rates for elbow arthroplasty are relatively high when compared to hip and knee arthroplasty. Failure is commonly due to aseptic loosening that is a likely consequence of overloading of the implants. This has resulted in implant manufacturers and surgeons recommending long-term activity restrictions to patients post-operatively. There are no standardised post-operative guidelines after elbow arthroplasty as the evidence base in the literature is poor. More recent efforts have been made to rectify this global issue. Post-operative activity levels have been reviewed with regards to other joints like the knee, hip and shoulder. However, there is evidence that adherence to post-operative restrictions after hip arthroplasty can be expected in less than 75% of patients, and general patient non-compliance with instructions can be as high as 27.5% after all orthopaedic procedures. The investigators could only find one single publication regarding patient compliance with activity restrictions after elbow arthroplasty, and this was over a decade ago. An awareness of patient comprehension and compliance with post-operative activity restriction with help surgeons and allied health professionals counsel patients more effectively pre-operatively and post-operatively.

The purpose of our study is to determine the overall level of activity and percentage of patients participating in moderate demand and high demand activities. The authors would also explore patient recall of activity restrictions and correlate this with their current activity levels.

In the literature, data regarding the specific activities performed by patients after total elbow arthroplasty are lacking. Knowledge of patient understanding of postoperative restrictions, as well as their compliance, may help improve preoperative and postoperative counselling of patients undergoing total elbow arthroplasty and help us understand the true relationship between activity and mechanical failure.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Shropshire
      • Oswestry, Shropshire, United Kingdom, SY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Gopikanthan Manoharan
        • Sub-Investigator:
          • Amrit Jah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participant who have had elbow replacement at our hospital.

Description

Inclusion Criteria:

  • All patients who have had elbow arthroplasty (total or hemi) for any indication. Minimum 6 months follow-up.

Exclusion Criteria:

  • Radial head replacement.
  • Less than 6 months follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine what activities patients are undertaking after elbow arthroplasty
Time Frame: From the time of their surgery until now, a minimum of 6 months since surgery.
Explore patient activity after elbow arthroplasty and their recollection of activity restrictions placed as part of the post-operative protocol as part of standard care.
From the time of their surgery until now, a minimum of 6 months since surgery.
Oxford Elbow Score
Time Frame: From the time of their surgery until now, a minimum of 6 months since surgery.
Validated questionnaire. 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.
From the time of their surgery until now, a minimum of 6 months since surgery.
Elbow replacement surgery and activities performed after the operation
Time Frame: From the time of their surgery until now, a minimum of 6 months since surgery.
Non-validated questionnaire regarding activities performed after operation to assist us to understand and convey to other patients about what activities people can do after elbow replacement, along with employment status, whether the participant has a physically demanding job and whether they are still taking medication for their replaced elbow joint.
From the time of their surgery until now, a minimum of 6 months since surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL1 900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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