Prospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Feb 18, 2024; 15(2): 156-162
Published online Feb 18, 2024. doi: 10.5312/wjo.v15.i2.156
High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis
Marc Randall Kristensen Nyring, Bo Sanderhoff Olsen, Alexander Amundsen, Jeppe Vejlgaard Rasmussen
Marc Randall Kristensen Nyring, Bo Sanderhoff Olsen, Alexander Amundsen, Jeppe Vejlgaard Rasmussen, Section for Shoulder and Elbow Surgery, Department of Orthopaedic Surgery, Herlev and Gentofte University Hospital, Hellerup 2900, Denmark
Author contributions: Nyring MRK contributed to data collection, design of the study, data analysis, and draft of manuscript; Olsen BS contributed to design of the study and review of manuscript; Amundsen A contributed to data collection, review of manuscript; Rasmussen JV contributed to design of the study and review of manuscript; and all authors have read and approve the final manuscript.
Institutional review board statement: The study is conducted according to the ethics outlined in the Helsinki Declaration. A permission to handle and store data has been obtained from the Danish Data Protection Agency (No. 2012-58-0004). The study was evaluated by the regional Research Ethics Committee and it was decided that the study did not need approval (No. H-17003344). All patients have given informed consent prior to participation. The Ethics Committee/Institutional Review Board is from “Region Hovedstaden”. “Region Hovedstaden” is the overall organization that manages all hospitals in the capital region of Denmark, including Herlev and Gentofte Hospital, to which the authors are affiliated.
Informed consent statement: Due to Danish regulations, written consent was not necessary since the treatment was the standard treatment at the hospital, just with extra follow-up visits. However, all patients have given informed oral consent to participation.
Conflict-of-interest statement: The authors Bo S Olsen, Alexander Amundsen, and Jeppe V Rasmussen received institutional support for conducting the study “Functional outcome and complications after Global Unite prostheses” which provided data for the present study. In addition, Bo S Olsen and Jeppe V Rasmussen are paid speakers for DePuy Synthes (Raynham, Massachusetts, United States of America).
Data sharing statement: Data will be made available on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Marc Randall Kristensen Nyring, MD, Doctor, Researcher, Section for Shoulder and Elbow Surgery, Department of Orthopaedic Surgery, Herlev and Gentofte University Hospital, 12 Gentofte Hospitalsvej, Hellerup 2900, Denmark. marcrandallkristensen@gmail.com
Received: October 4, 2023
Peer-review started: October 4, 2023
First decision: December 12, 2023
Revised: December 20, 2023
Accepted: January 8, 2024
Article in press: January 8, 2024
Published online: February 18, 2024
Abstract
BACKGROUND

The minimal clinically important difference (MCID) is defined as the smallest meaningful change in a health domain that a patient would identify as important. Thus, an improvement that exceeds the MCID can be used to define a successful treatment for the individual patient.

AIM

To quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.

METHODS

Patients were treated with the Global Unite total shoulder platform arthroplasty between March 2017 and February 2019 at Herlev and Gentofte Hospital, Denmark. The patients were evaluated preoperatively and 3 months, 6 months, 12 months, and 24 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder index (WOOS), Oxford Shoulder Score (OSS) and Constant-Murley Score (CMS). The rate of clinically relevant improvement was defined as the proportion of patients who had an improvement 24 months postoperatively that exceeded the MCID. Based on previous literature, MCID for WOOS, OSS, and CMS were defined as 12.3, 4.3, and 12.8 respectively.

RESULTS

Forty-nine patients with a Global Unite total shoulder platform arthroplasty were included for the final analysis. Mean age at the time of surgery was 66 years (range 49.0-79.0, SD: 8.3) and 65% were women. One patient was revised within the two years follow-up. The mean improvement from the preoperative assessment to the two-year follow-up was 46.1 points [95% confidence interval (95%CI): 39.7-53.3, P < 0.005] for WOOS, 18.2 points (95%CI: 15.5-21.0, P < 0.005) for OSS and 37.8 points (95%CI: 31.5-44.0, P < 0.005) for CMS. Two years postoperatively, 41 patients (87%) had an improvement in WOOS that exceeded the MCID, 45 patients (94%) had an improvement in OSS that exceeded the MCID, and 42 patients (88%) had an improvement in CMS that exceeded the MCID.

CONCLUSION

Based on three shoulder-specific outcome measures we find that approximately 90% of patients has a clinically relevant improvement. This is a clear message when informing patients about their prognosis.

Keywords: Minimal clinically important difference, Patient reported outcome measures, Glenohumeral osteoarthritis, Anatomical total shoulder arthroplasty, Clinically relevant improvement

Core Tip: In this study, we present a new approach for analyzing and interpreting improvement in patient-reported outcome measures (PROM) scores by linking the improvement in PROM scores to the minimal clinical difference for each patient. We found that approximately 90% of patients treated with an anatomical total shoulder arthroplasty for glenohumeral osteoarthritis had a clinically relevant improvement two years postoperatively.