Elbow ArthropathyEAANCT06895239
Elbow Arthroplasty and Patient Reported Post-operative Activities
An observational study of Elbow Arthropathy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Arthropathy
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participant who have had elbow replacement at our hospital.
Who may be able to join
- All patients who have had elbow arthroplasty (total or hemi) for any indication. Minimum 6 months follow-up.
Who cannot join
- Radial head replacement.
- Less than 6 months follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
Julie Steen, 01691404418, julie.steen@nhs.net
Gopikanthan Manoharan
About this study
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.
Read the 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.
- Conditions
- Elbow Arthropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine what activities patients are undertaking after elbow arthroplasty
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.
Measured: From the time of their surgery until now, a minimum of 6 months since surgery.
Oxford Elbow Score
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.
Measured: From the time of their surgery until now, a minimum of 6 months since surgery.
Elbow replacement surgery and activities performed after the operation
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.
Measured: From the time of their surgery until now, a minimum of 6 months since surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Elbow ArthropathyStudies 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
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895239
- Sponsor's protocol ID
- RL1 900
- Acronym
- EAA
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011 Mar;20(2):273-80. doi: 10.1016/j.jse.2010.06.007. Epub 2010 Oct 15.
PubMed 20951063Samdanis V, Manoharan G, Jordan RW, Watts AC, Jenkins P, Kulkarni R, Thomas M, Rangan A, Hay SM. Indications and outcome in total elbow arthroplasty: A systematic review. Shoulder Elbow. 2020 Oct;12(5):353-361. doi: 10.1177/1758573219873001. Epub 2019 Sep 12.
PubMed 33093874Kholinne E, Arya A, Jeon IH. Complications of modern design total elbow replacement. J Clin Orthop Trauma. 2021 May 15;19:42-49. doi: 10.1016/j.jcot.2021.05.008. eCollection 2021 Aug.
PubMed 34141570Macken AA, Prkic A, van Oost I, Spekenbrink-Spooren A, The B, Eygendaal D. Implant survival of total elbow arthroplasty: analysis of 514 cases from the Dutch Arthroplasty Registry. Bone Jt Open. 2023 Feb 21;4(2):110-119. doi: 10.1302/2633-1462.42.BJO-2022-0152.R1.
PubMed 37051858Badre A, King GJW. Primary total elbow arthroplasty. J Clin Orthop Trauma. 2021 Apr 20;18:66-73. doi: 10.1016/j.jcot.2021.04.015. eCollection 2021 Jul.
PubMed 33996451Dam WV, Meijering D, Stevens M, Boerboom AL, Eygendaal D. Postoperative management of total elbow arthroplasty: Results of a European survey among orthopedic surgeons. PLoS One. 2022 Nov 14;17(11):e0277662. doi: 10.1371/journal.pone.0277662. eCollection 2022.
PubMed 36374842Burden EG, Evans JP, Smith CD. Lifting limitations following elbow arthroplasty: A survey of British Elbow and Shoulder Society members. Shoulder Elbow. 2024 Oct;16(6):641-645. doi: 10.1177/17585732231170292. Epub 2023 Apr 20.
PubMed 39650263
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Arthroplasty and Patient Reported Post-operative Activities
- ClinicalTrials.gov ID
- NCT06895239
- Acronym / sponsor ID
- EAA / RL1 900
- Conditions
- Elbow Arthropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Mar 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant who have had elbow replacement at our hospital.
Key inclusion criteria (1 listed)
- All patients who have had elbow arthroplasty (total or hemi) for any indication. Minimum 6 months follow-up.
Key exclusion criteria (2 listed)
- Radial head replacement.
- Less than 6 months follow-up.
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 20951063Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011 Mar;20(2):273-80. doi: 10.1016/j.jse.2010.06.007. Epub 2010 Oct 15.
- Results publication: PubMed 33093874Samdanis V, Manoharan G, Jordan RW, Watts AC, Jenkins P, Kulkarni R, Thomas M, Rangan A, Hay SM. Indications and outcome in total elbow arthroplasty: A systematic review. Shoulder Elbow. 2020 Oct;12(5):353-361. doi: 10.1177/1758573219873001. Epub 2019 Sep 12.
- Results publication: PubMed 34141570Kholinne E, Arya A, Jeon IH. Complications of modern design total elbow replacement. J Clin Orthop Trauma. 2021 May 15;19:42-49. doi: 10.1016/j.jcot.2021.05.008. eCollection 2021 Aug.
- Results publication: PubMed 37051858Macken AA, Prkic A, van Oost I, Spekenbrink-Spooren A, The B, Eygendaal D. Implant survival of total elbow arthroplasty: analysis of 514 cases from the Dutch Arthroplasty Registry. Bone Jt Open. 2023 Feb 21;4(2):110-119. doi: 10.1302/2633-1462.42.BJO-2022-0152.R1.
- Results publication: PubMed 33996451Badre A, King GJW. Primary total elbow arthroplasty. J Clin Orthop Trauma. 2021 Apr 20;18:66-73. doi: 10.1016/j.jcot.2021.04.015. eCollection 2021 Jul.
- Results publication: PubMed 36374842Dam WV, Meijering D, Stevens M, Boerboom AL, Eygendaal D. Postoperative management of total elbow arthroplasty: Results of a European survey among orthopedic surgeons. PLoS One. 2022 Nov 14;17(11):e0277662. doi: 10.1371/journal.pone.0277662. eCollection 2022.
- Results publication: PubMed 39650263Burden EG, Evans JP, Smith CD. Lifting limitations following elbow arthroplasty: A survey of British Elbow and Shoulder Society members. Shoulder Elbow. 2024 Oct;16(6):641-645. doi: 10.1177/17585732231170292. Epub 2023 Apr 20.
- Individual participant dataSharing planned: No
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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.
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 Arthropathy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS 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 2 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: opening soon, as of the sponsor's last update on 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (01691404418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06895239, which also lists 7 linked publications.
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 7 Aug 2025.