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Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial.

ABSTRACT: BACKGROUND: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). MATERIALS AND METHODS:A 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. DISCUSSION:Findings 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 REGISTRATION:Clinicaltrials.gov, NCT03877315 . Registered on 13 March 2019.

SUBMITTER: Issa Z

PROVIDER: S-EPMC6626414 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial.

Issa Zaid Z Rasmussen Jeppe Vejlgaard JV Petersen John Kloth JK Schantz Kim K Brorson Stig S

Trials 20190712 1

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

PMID: 31300025

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Project description:BackgroundGlenohumeral 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 methodsThis 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.DiscussionTo 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 registrationClinicalTrials.gov NCT04105478 . Registered on 25 September 2019.

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.

Project description:IntroductionReadmissions following orthopaedic surgery are associated with worse outcomes and increased healthcare costs. Studies investigating trends, causes, and costs of readmissions following primary total shoulder arthroplasty (TSA) for the indication of glenohumeral osteoarthritis (OA) are limited. The objective was to compare: 1) patient-demographics of those readmitted and not readmitted within 90-days following primary TSA for OA; 2) causes of readmissions and 3) associated costs.MethodsA retrospective query from 2005 to 2014 was performed using a nationwide administrative claims database. The study group consisted of patients readmitted within 90-days following primary TSA for glenohumeral OA, whereas patients not readmitted served as controls. Causes of readmission were stratified into the following groups: cardiovascular, hematological, endocrine, gastrointestinal (GI), musculoskeletal (MSK), neoplastic, neurological, pulmonary, infectious, renal, and miscellaneous causes. Patient demographics were compared, in addition to the frequency of the causes of readmissions, and their associated costs. Chi-square analyses compared demographics between groups. Analysis of variance was utilized to determine differences in 90-day costs for the causes of readmission. A p-value less than 0.001 was significant.ResultsThe overall 90-day readmission rate was 2.4% (3432/143,878). Patients readmitted following primary TSA were more likely to be over the age of 75, female, and higher prevalence of comorbid conditions, including psychiatric and medical conditions. Readmitted patients had a higher overall comorbidity burden per mean Elixhauser-Comorbidity Index (ECI) scores (10 vs. 7,p < .0001). The leading cause of readmissions were due to MSK (17.34%), cardiac (16.28%), infectious (16.26%), and gastrointestinal (11.64%) etiologies. There were differences in the mean 90-day costs of care for the various causes of readmissions, with the leading cost of readmissions being cardiac causes ($10,913.70) and MSK ($10,590.50) etiologies.ConclusionPatients with greater comorbidities experienced increased incidence of readmission following TSA for glenohumeral OA. Cardiac and MSK etiologies were the primary cause of readmissions.Level of evidenceIII.

Project description:BackgroundThere is an existing perception that obesity has a negative impact on complications following total knee arthroplasty (TKA). However, data on the impact of obesity levels on patient-reported outcomes (PROMs) is sparse. We investigated the association between different obesity classes with PROMs among patients who underwent TKA.MethodsWe performed retrospective secondary analyses on data extracted from the total joint replacement data repository (Alberta, Canada) managed by the Alberta Bone and Joint Health Institute (ABJHI). Patients had WOMAC and EQ5D scores measured at baseline in addition to 3 and/or 12 months following TKA. Patients were stratified according to the World Health Organization (WHO) classification, into five body mass index (BMI) groups of normal, overweight, BMI class I, BMI class II, and BMI class III. The association between BMI and mean changes in WOMAC subscales (pain, function, and stiffness) and EQ-5D-5L index over the time intervals of baseline to 3 months and 3 to 12 months following TKA was assessed. Linear mixed-effects models were used, and the models were adjusted for age, sex, length of surgery, comorbidities, year of surgery, and geographical zone where the surgery was performed.ResultsMean age was 65.5 years (SD = 8.7). Postoperatively, there was a significant improvement (p < 0.001) in WOMAC subscales of patient-reported pain, function, and stiffness, as well as EQ-5D-5L regardless of BMI group. Although, patients in BMI class II and class III reported significantly improved pain 3 months after TKA compared to those with normal BMI, all BMI groups attained similar level of pain reduction at 12 months after TKA. The greatest improvement in all WOMAC subscales, as well as EQ5D index, occurred between baseline and 3 months (adjusted p < 0.0001).ConclusionThe findings indicate that patients reported improved pain, function, and stiffness across all BMI groups following TKA. Patients with BMI classified as obese reported similar benefits to those with BMI classified as normal weight. These results may help health care providers to discuss expectations regarding the TKA recovery in terms of pain, function, and quality of life improvements with their TKA candidates.

Dataset Information

Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial.

Publications

Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial.

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