A Multi-Centre, Randomized Controlled Trial Comparing A Second-Generation Uncemented Trabecular Metal-Backed vs. Cemented Polyethylene Glenoid Component in Total Shoulder Arthroplasty: Two-Year Results

OrthoMedia ◽  
2022 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Arthroplasty ◽  
Second Generation ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Glenoid Component ◽  
Trabecular Metal ◽  
Randomized Controlled

scholarly journals Two-year results of a multi-centre, randomized controlled trial comparing a second-generation uncemented trabecular metal-backed versus cemented polyethylene glenoid component in total shoulder arthroplasty

2021 ◽  
Vol 2 (9) ◽  
pp. 728-736
Author(s):  
Patrick Y. K. Chin ◽  
William D. Regan ◽  
Derek Plausinis ◽  
Zane D. Zarzour ◽  
Fay Leung ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Second Generation ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Glenoid Component ◽  
Trabecular Metal ◽  
Metal Debris ◽  
Randomized Controlled ◽  
Patient Reported

Aims To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Methods Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed. Results A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted. Conclusion Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728–736.

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

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Marc Randall Kristensen Nyring ◽  
Bo S. Olsen ◽  
Müjgan Yilmaz ◽  
Michael M. Petersen ◽  
Gunnar Flivik ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Shoulder Arthroplasty ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Additional Patient ◽  
Randomized Controlled ◽  
Humeral Component ◽  
Patient Reported ◽  
Glenohumeral Osteoarthritis

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

scholarly journals Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elaine Z. Shing ◽  
Daniel Leas ◽  
Caleb Michalek ◽  
Meghan K. Wally ◽  
Nady Hamid
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Arthroplasty ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Orthopedic Procedures ◽  
Secondary Outcome ◽  
Prescription Opioids ◽  
Randomized Controlled ◽  
Link Type ◽  
Opioid Crisis

Abstract Background The medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics. Methods We developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24 h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status. Discussion We describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis. Trial registration The protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783) on November 25, 2019, retrospectively registered

scholarly journals Total shoulder arthroplasty with a second-generation tantalum trabecular metal-backed glenoid component

2016 ◽  
Vol 98-B (1) ◽  
pp. 75-80 ◽  
Author(s):  
G. Merolla ◽  
P. Chin ◽  
T. M. Sasyniuk ◽  
P. Paladini ◽  
G. Porcellini
Keyword(s):  
Shoulder Arthroplasty ◽  
Second Generation ◽  
Total Shoulder Arthroplasty ◽  
Glenoid Component ◽  
Trabecular Metal

Prospective, Blinded, Randomized Controlled Trial of Stemless Versus Stemmed Humeral Components in Anatomic Total Shoulder Arthroplasty

2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
J. Michael Wiater ◽  
Jonathan C. Levy ◽  
Stephen A. Wright ◽  
Stephen F. Brockmeier ◽  
Thomas R. Duquin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Arthroplasty ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Randomized Controlled

scholarly journals Accelerated Shoulder Rehabilitation after Reverse Total Shoulder Arthroplasty for Atraumatic Osteoarthritis: Study Protocol for a Single Center Randomized Controlled Trial

2019 ◽  
Author(s):  
Avais Raja ◽  
Travis Cambronne ◽  
Michael R Walsh
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Arthroplasty ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Reverse Total Shoulder Arthroplasty ◽  
Single Center ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Shoulder Motion ◽  
Reverse Total Shoulder

Abstract Background Reverse total shoulder arthroplasty has been successful in patients suffering from advanced degenerative osteoarthritis with rotator cuff insufficiency. The currently practiced physical rehabilitation after a shoulder rehabilitation does not allow shoulder motion until 6 weeks post-operatively. These patients are required to be in a sling to assist the patient in immobilizing the operated shoulder. An accelerated rehabilitation with immediate active shoulder motion has not been studied in the setting of a revere total shoulder arthroplasty. Methods This is a single center and single surgeon operated, randomized controlled trial. The primary objective is to compare patient reported shoulder function using the American Shoulder and Elbow Society (ASES) score and shoulder range of motion in patients undergoing the traditional physical rehabilitation and accelerated shoulder rehabilitation post reverse total shoulder arthroplasty. Secondary outcomes will include the Simple Shoulder Test (SST) score, Patient Reported Outcome Information System (PROMIS) Global Health-10, radiological parameters and subscapularis tear on ultrasound. Discussion The study will assess the effectiveness of an accelerated shoulder rehabilitation with immediate active shoulder motion after a reverse total shoulder arthroplasty in patients with atraumatic osteoarthritis.

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