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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
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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The British Editorial Society of Bone & Joint Surgery
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479846/ https://www.ncbi.nlm.nih.gov/pubmed/34488426 http://dx.doi.org/10.1302/2633-1462.29.BJO-2021-0073.R1 |
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author | Chin, Patrick Y. K. Regan, William D. Plausinis, Derek Zarzour, Zane D. Leung, Fay Sasyniuk, Treny M. Lim, Brendan Sayre, Eric C. |
author_facet | Chin, Patrick Y. K. Regan, William D. Plausinis, Derek Zarzour, Zane D. Leung, Fay Sasyniuk, Treny M. Lim, Brendan Sayre, Eric C. |
author_sort | Chin, Patrick Y. K. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8479846 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | The British Editorial Society of Bone & Joint Surgery |
record_format | MEDLINE/PubMed |
spelling | pubmed-84798462021-10-14 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 Chin, Patrick Y. K. Regan, William D. Plausinis, Derek Zarzour, Zane D. Leung, Fay Sasyniuk, Treny M. Lim, Brendan Sayre, Eric C. Bone Jt Open Shoulder & Elbow 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. The British Editorial Society of Bone & Joint Surgery 2021-09-07 /pmc/articles/PMC8479846/ /pubmed/34488426 http://dx.doi.org/10.1302/2633-1462.29.BJO-2021-0073.R1 Text en © 2021 Author(s) et al. https://creativecommons.org/licenses/by-nc-nd/4.0/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/ |
spellingShingle | Shoulder & Elbow Chin, Patrick Y. K. Regan, William D. Plausinis, Derek Zarzour, Zane D. Leung, Fay Sasyniuk, Treny M. Lim, Brendan Sayre, Eric C. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Shoulder & Elbow |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479846/ https://www.ncbi.nlm.nih.gov/pubmed/34488426 http://dx.doi.org/10.1302/2633-1462.29.BJO-2021-0073.R1 |
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