Elbow Arthroplasty and Patient Reported Post-operative Activities

NCT06895239 | Not Yet Recruiting

• 1 other identifier: RL1 900
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Elbow Arthropathy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From the time of their surgery until now, a minimum of 6 months since surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant who have had elbow replacement at our hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 20951063 BACKGROUND

• Samdanis 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.

  PMID: 33093874 RESULT

• Kholinne 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.

  PMID: 34141570 RESULT

• Macken 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.

  PMID: 37051858 RESULT

• Badre 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.

  PMID: 33996451 RESULT

• Dam 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.

  PMID: 36374842 RESULT

• Burden 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.

  PMID: 39650263 RESULT

Central Study Contacts

Julie Steen

CONTACT

01691404418; julie.steen@nhs.net

Jayne Edwards

CONTACT

01691404143; jayne.edwards5@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: March 26, 2025
• Study Start: September 30, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)