Not yet recruiting NCT07060469

Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.

— Observational Shoulder Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Shoulder Osteoarthritis. Basic parameters: from 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Analysis of Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty in Patients Over 70: A Retrospective Single Unit Single Surgeon Study

Overview

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.

Detailed description

Despite numerous studies, the literature presents conflicting evidence regarding the comparative effectiveness of anatomic shoulder arthroplasty (aTSA) versus reverse shoulder arthroplasty in primary humeral osteoarthritis among patients aged over 70 years.

There is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.

This retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis.

Primary outcome measures

Rotator cuff failure [Time frame: within the last 10 years]

Secondary outcome measures (1)

Oxford Shoulder Score (OSS) [Time frame: within the last 7 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Under 70 years of age Shoulder replacement for trauma/tumour

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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 36911771
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 34293419
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 37075936
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 37588441
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 33484829

Identifiers

NCT: NCT07060469 · RL1 905 · RL1 905

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗