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

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.

SUBMITTER: Nyring MRK

PROVIDER: S-EPMC7541322 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Nyring Marc Randall Kristensen MRK Nyring Marc Randall Kristensen MRK Olsen Bo S BS Yilmaz Müjgan M Petersen Michael M MM Flivik Gunnar G Rasmussen Jeppe V JV

Trials 20201007 1

<h4>Background</h4>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 ...[more]

PMID: 33028390

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Project description:BackgroundAnatomical total shoulder arthroplasty (aTSA) has been used to manage degenerative diseases such as primary osteoarthritis. An increase in the use of this procedure has led to several developments in humeral and glenoid components to improve patient outcomes. This study aimed to compare clinical and radiological outcomes of the newly-introduced convertible metal-backed glenoid components with cemented polyethylene glenoid components in aTSA, and to determine whether the new component would be comparable to a conventional one for reducing the burden of future revision or conversion surgeries.MethodsMedical records of fifty patients who underwent aTSA with at least two years of follow-up were retrospectively reviewed. Eighteen patients received convertible metal-backed glenoid components with vitamin E1-coated liner (MB group), while thirty-two patients received conventional cemented polyethylene glenoid components (PE group). Pre- and postoperative clinical and radiological outcomes (acromion-greater tuberosity angle [AGA] and humeral lateral offset [LO]) at final follow-up were assessed. Radiolucent lines (RLLs) and loosening around the humeral and glenoid components were also evaluated.ResultsClinical outcomes improved after surgery in both groups (all p < 0.001). The arc of rotation measured by AGA improved postoperatively in both groups (all p < 0.001), and AGA and LO were not different according to the type of glenoid components (all p > 0.05). Overall complication rates including RLLs of PE and MB groups were 43.8% (14/32) and 16.7% (3/18), respectively (p = 0.031). Although the PE group had more RLLs than did the MB group (p < 0.05), related symptoms and/or glenoid implant loosening were not observed in both groups. Subscapularis failure occurred in two patients in the PE group and in one in the MB group.ConclusionThe convertible metal-backed glenoid implant with vitamin E1-coated liner may be a good alternative for considering the potential for an easier conversion to reverse total shoulder arthroplasty.

Project description:BackgroundThe 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.AimTo quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.MethodsPatients 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.ResultsForty-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.ConclusionBased 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.

Dataset Information

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

Publications

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

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