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

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Abstract

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.

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Most cited references 30

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The American Shoulder and Elbow Surgeons have adopted a standardized form for assessment of the shoulder. The form has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain and instability and an activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The patient can complete the self-evaluation portion of the questionnaire in the absence of a physician. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). It is hoped that adoption of this instrument to measure shoulder function will facilitate communication between investigators, stimulate multicenter studies, and encourage validity testing of this and other available instruments to measure shoulder function and outcome. Copyright © 1994 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

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Scoring systems for the functional assessment of the shoulder.

Sharon Griffin, Alexandra Kirkley, Katie N Dainty (2003)

A number of instruments have been developed to measure the quality of life in patients with various conditions of the shoulder. Older instruments appear to have been developed at a time when little information was available on the appropriate methodology for instrument development. Much progress has been made in this area, and currently an appropriate instrument exists for each of the main conditions of the shoulder. Investigators planning clinical trials should select modern instruments that have been developed with appropriate patient input for item generation and reduction, and established validity and reliability. Among the other factors discussed in this review, responsiveness of an instrument is an important consideration as it can serve to minimize the sample size for a proposed study. The shoulder instruments reviewed include the Rating Sheet for Bankart Repair (Rowe), ASES Shoulder Evaluation Form, UCLA Shoulder Score, The Constant Score, Disabilities of the Arm, Shoulder and Hand (DASH), the Shoulder Rating Questionnaire, the Simple Shoulder Test (SST), the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Western Ontario Rotator Cuff Index (WORC), the Western Ontario Shoulder Instability Index (WOSI), Rotator Cuff Quality of Life (RC-QOL), and the Oxford Shoulder Scores (OSS).

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Author and article information

Contributors

Patrick Y. K. Chin: Role: Clinical Associate Professor, Department of Orthopaedics

William D. Regan: Role: Associate Professor, Department of Orthopedics & Head, Division of Arthroscopy

Derek Plausinis: Role: Clinical Associate Professor, Department of Orthopaedics

Zane D. Zarzour: Role: Clinical Lecturer, Department of Orthopaedics

Fay Leung: Role: Clinical Associate Professor, Department of Orthopaedics

Treny M. Sasyniuk:

ORCID: https://orcid.org/0000-0003-4224-9325

Role: Research Manager, Joint Preservation Centre of BC

Brendan Lim: Role: Research Coordinator, Joint Preservation Centre of BC

Eric C. Sayre: Role: Biostatistican

Journal

Journal ID (nlm-ta): Bone Jt Open

Journal ID (iso-abbrev): Bone Jt Open

Journal ID (publisher-id): BJO

Title: Bone & Joint Open

Publisher: The British Editorial Society of Bone & Joint Surgery (London )

ISSN (Electronic): 2633-1462

Publication date (Electronic): 07 September 2021

Publication date Collection: September 2021

Volume: 2

Issue: 9

Pages: 728-736

Affiliations

[1 ]org-divisionThe University of British Columbia , Vancouver, Canada

[2 ]org-divisionThe University of Victoria , Victoria, Canada

[3 ]org-divisionArthritis Research Canada , Richmond, Canada

Author notes

Correspondence should be sent to Treny M. Sasyniuk. E-mail: sasyniuk@ 123456gmail.com

Author information

Treny M. Sasyniuk https://orcid.org/0000-0003-4224-9325

Article

Publisher ID: BJO-2-728

DOI: 10.1302/2633-1462.29.BJO-2021-0073.R1

PMC ID: 8479846

PubMed ID: 34488426

SO-VID: fff02d27-edfc-4ed3-8713-b2d310cdc69b

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/

History

Custom metadata

odf2nlm-version 2.0

price $2.00

principal-institution University of British Columbia, Vancouver, Canada

article-type Shoulder & Elbow

coi-statement P. Y. K. Chin reports consultancy fees from Zimmer Biomet. Z. Zarzour, W. D. Regan, B. Lim, D. Plausinis, F. Leung, T. Sasyniuk, and P. Y. K. Chin report an institutional grant from Zimmer Biomet to fund the research for this study.

Keywords: total shoulder arthroplasty,uncemented tm vs cemented polyethylene glenoid,randomized controlled trial,disease-specific quality of life,trabecular metal,glenoids,metal debris,revision surgeries,patient-reported outcome measures (proms),glenoid implant,shoulder,osteoarthritis

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Keywords: total shoulder arthroplasty, uncemented tm vs cemented polyethylene glenoid, randomized controlled trial, disease-specific quality of life, trabecular metal, glenoids, metal debris, revision surgeries, patient-reported outcome measures (proms), glenoid implant, shoulder, osteoarthritis

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

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Abstract

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Most cited references 30

A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

A standardized method for the assessment of shoulder function.

Scoring systems for the functional assessment of the shoulder.

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Author notes

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