Abstract
BackgroundStemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used for glenohumeral osteoarthritis since 2004 (Hawi, et al. BMC Musculoskelet Disord 17:376, 2016). The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients’ anatomy; preserving humeral bone stock; and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty (TSA).Materials and methodsA randomized clinical trial will be conducted. Eighty patients with clinical and radiological signs of primary or post-traumatic glenohumeral osteoarthritis, computed tomography (CT) scan-verified adequate glenoid bone stock, and no total rupture of rotator cuff tendons verified by a magnetic resonance imaging (MRI) scan will be randomly allocated to a stemless or stemmed TSA. The primary outcome will be the Western Ontario Osteoarthritis Shoulder (WOOS) score at 12 months. Secondary outcomes are the WOOS score at three months and the Oxford Shoulder Score (OSS) and EQ-5D at 3 and 12 months. All complications, including glenoid and humeral component loosening, instability, rotator cuff tear, intraoperative and postoperative periprosthetic fracture, nerve injury, infection, deltoid injury, and symptomatic deep venous thrombosis, will be reported.DiscussionFindings will provide patients with better information about the potential benefits and harms of stemless and stemmed TSA and will assist shoulder surgeons and patients in decision-making.Trial registrationClinicaltrials.gov, NCT03877315. Registered on 13 March 2019.
Highlights
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used for glenohumeral osteoarthritis since 2004 (Hawi, et al BMC Musculoskelet Disord 17:376, 2016)
The stemless shoulder arthroplasty system with uncemented metaphyseal fixation has been used in Europe for glenohumeral osteoarthritis since 2004
With an accepted clinically meaningful change (ACMC) of 12.5% and a standard deviation (SD) of ±20.0, which we found from our retrospective evaluation of patients operated with stemless total shoulder arthroplasty (TSA) in our department, we need to include 64 patients, 32 in each group, to be 80% sure that the lower limit of a one-sided 95% confidence interval will be above the non-inferiority threshold of – 12.5%
Summary
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used for glenohumeral osteoarthritis since 2004 (Hawi, et al BMC Musculoskelet Disord 17:376, 2016). The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients’ anatomy; preserving humeral bone stock; and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty (TSA). Glenohumeral joint osteoarthritis is a common cause of shoulder pain, affecting up to one-third of patients aged > 60 years [1]. The stemless shoulder arthroplasty system with uncemented metaphyseal fixation has been used in Europe for glenohumeral osteoarthritis since 2004. The contraindications for anatomical stemless TSA are acute proximal humerus fracture, inadequate metaphyseal bone stock, and rotator cuff insufficiency [4, 5]
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