NCT07060469

Brief Summary

This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

April 23, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rotator cuff failure

    Information will be retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty. This will indicate the failure rate of these types of shoulder replacement.

    within the last 10 years

Secondary Outcomes (1)

  • Oxford Shoulder Score (OSS)

    within the last 7 years

Study Arms (3)

Anatomic Shoulder Arthroplasty

Type of shoulder replacement

Hemiarthroplasty

Type of shoulder replacement

Reverse Shoulder Arthroplasty

Type of shoulder replacement

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who have had a shoulder replacement within the last 10 years anatomic, reverse, or hemi-arthroplasty and who are aged over 70 at the time of surgery will be included.

You may qualify if:

  • All genders Over 70 All ethnic groups Anatomic / Reverse / Hemi shoulder replacement

You may not qualify if:

  • Under 70 years of age Shoulder replacement for trauma/tumour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Hao KA, Boschert EN, O'Keefe DS, Saengchote SA, Schoch BS, Wright JO, Wright TW, Farmer KW, Struk AM, King JJ. Comparison of clinical outcomes of revision reverse total shoulder arthroplasty for failed primary anatomic vs. reverse shoulder arthroplasty. JSES Int. 2022 Dec 16;7(2):257-263. doi: 10.1016/j.jseint.2022.11.003. eCollection 2023 Mar.

    PMID: 36911771BACKGROUND
  • Heifner JJ, Kumar AD, Wagner ER. Glenohumeral osteoarthritis with intact rotator cuff treated with reverse shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2021 Dec;30(12):2895-2903. doi: 10.1016/j.jse.2021.06.010. Epub 2021 Jul 20.

    PMID: 34293419BACKGROUND
  • Orvets ND, Chan PH, Taylor JM, Prentice HA, Navarro RA, Garcia IA. Similar rates of revision surgery following primary anatomic compared with reverse shoulder arthroplasty in patients aged 70 years or older with glenohumeral osteoarthritis: a cohort study of 3791 patients. J Shoulder Elbow Surg. 2023 Sep;32(9):1893-1900. doi: 10.1016/j.jse.2023.03.021. Epub 2023 Apr 17.

    PMID: 37075936BACKGROUND
  • Su F, Nuthalapati P, Feeley BT, Lansdown DA. Outcomes of anatomic and reverse total shoulder arthroplasty in patients over the age of 70: a systematic review. JSES Rev Rep Tech. 2023 Mar 4;3(2):181-188. doi: 10.1016/j.xrrt.2023.02.003. eCollection 2023 May.

    PMID: 37588441BACKGROUND
  • Jensen AR, Tangtiphaiboontana J, Marigi E, Mallett KE, Sperling JW, Sanchez-Sotelo J. Anatomic total shoulder arthroplasty for primary glenohumeral osteoarthritis is associated with excellent outcomes and low revision rates in the elderly. J Shoulder Elbow Surg. 2021 Jul;30(7S):S131-S139. doi: 10.1016/j.jse.2020.11.030. Epub 2021 Jan 20.

    PMID: 33484829BACKGROUND

Study Officials

  • Mr I Tsolis

    The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 23, 2025

First Posted

July 11, 2025

Study Start

July 31, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share