Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis-study protocol for a randomized controlled trial

Marc Randall Kristensen Nyring, Bo S Olsen, Müjgan Yilmaz, Michael M Petersen, Gunnar Flivik, Jeppe V Rasmussen, Marc Randall Kristensen Nyring, Bo S Olsen, Müjgan Yilmaz, Michael M Petersen, Gunnar Flivik, Jeppe V Rasmussen

Abstract

Background: Glenohumeral osteoarthritis can, in the most severe cases, require surgery with insertion of a shoulder arthroplasty. A design with a stem in the humeral bone canal is currently regarded as the standard treatment option in patients who have an intact rotator cuff function, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component, stem-related complications can be reduced. The aim of this study is to compare the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive stemmed total shoulder arthroplasty (control group).

Materials and methods: This is a randomized controlled trial comparing the stemless and the stemmed total shoulder arthroplasty. All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be offered participation. The following exclude from participation: below 18 years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff, poor bone quality, and ASA groups 4-5. A total of 122 patients will be included of which 56 will be part of a radiostereometric analysis (RSA) study of humeral component migration. The primary outcomes are magnitude of migration of the humeral component assessed by RSA and patient-reported outcome by Western Ontario Osteoarthritis of the Shoulder index (WOOS). The secondary outcomes are additional patient-reported outcomes, functional outcome, readmission, complications, revisions, and changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost-utility analysis). The patients are examined before the operation and 3, 6, 12, and 24 months postoperative.

Discussion: To our knowledge, RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function in a randomized clinical trial. Today, the two designs are considered equal in the treatment of osteoarthritis. The study will provide surgeons and patients with information about shoulder arthroplasty for osteoarthritis and assist them in decision-making.

Trial registration: ClinicalTrials.gov NCT04105478 . Registered on 25 September 2019.

Keywords: Glenohumeral osteoarthritis; Radiostereometric analysis; Shoulder prosthesis; Shoulder replacement; Stemless shoulder arthroplasty; Stemmed shoulder arthroplasty.

Conflict of interest statement

One of the authors (BO) has previously given a paid lecture to the manufacturer, Zimmer Biomet, and one of the authors (MP) has previously received funding (institutional research support) for other investigator-initiated and industry-initiated research studies from Zimmer Biomet. However, Zimmer Biomet has not had any role in the design of the study and will not be involved in execution of the study or analysis or interpretation of study results and have no influence on the decision to submit the results for publication.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. The expected flow of patients through the study
Fig. 2
Fig. 2
SPIRIT figure. Schedule of enrolment, interventions, and assessments of the 56 RSA patients
Fig. 3
Fig. 3
SPIRIT figure. Schedule of enrolment, interventions, and assessments of the 66 patients who are not a part of the RSA study

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