Elbow Arthroplasty and Patient Reported Post-operative Activities

NCT ID: NCT06895239

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

Countries

United Kingdom

Central Contacts

Julie Steen

Role: CONTACT

julie.steen@nhs.net

01691404418

Jayne Edwards

Role: CONTACT

jayne.edwards5@nhs.net

01691404143

Facility Contacts

Julie Steen

Role: primary

julie.steen@nhs.net

01691404418

References

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.

Reference Type: BACKGROUND

PMID: 20951063 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33093874 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34141570 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37051858 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33996451 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36374842 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39650263 (View on PubMed)

Other Identifiers

RL1 900

Identifier Type: -

Identifier Source: org_study_id