Short-term safety, function, and quality of life in patients treated with Univers Revers prosthesis: a multicenter 2-year follow-up case series.


Journal

Journal of shoulder and elbow surgery
ISSN: 1532-6500
Titre abrégé: J Shoulder Elbow Surg
Pays: United States
ID NLM: 9206499

Informations de publication

Date de publication:
Nov 2020
Historique:
received: 25 09 2019
revised: 20 01 2020
accepted: 21 01 2020
pubmed: 24 5 2020
medline: 10 3 2021
entrez: 24 5 2020
Statut: ppublish

Résumé

The use of reverse total shoulder arthroplasty (RTSA) has dramatically increased in recent years with the advent of new prosthesis designs regularly entering the market. We define the rate of local complications during the first 2 years after RTSA with the Univers Revers prosthesis and describe the changes in radiologic outcomes, as well as function, pain, satisfaction, and quality of life. This multicenter, prospective case series included rotator cuff tear arthropathy patients who underwent RTSA with the Univers Revers. Incidence percentages of complications and pathologic radiographic changes were documented. Mixed-model linear regression was used to examine changes in range of motion, shoulder function (Constant score, Shoulder Pain and Disability Index, Subjective Shoulder Value), and quality of life (EQ-5D-5L [European Quality of Life 5 Dimensions 5 Level] and EQ-VAS [EuroQol Visual Analog Scale]). Of 187 patients, 59.4% were women, and the mean age was 75.3 years (range, 56-91 years). Twenty-five percent of patients had a postoperative complication; 5 complications were severe (2.7%, 5 of 187), whereby 2 were implant related (1.1%; 95% confidence interval [CI], 0.1%-3.8%). The incidence of scapular notching was 10.6% (95% CI, 6.5%-16%). After 2 years, abduction, flexion, and abduction strength improved by 54° (95% CI, 50°-58°), 57° (95% CI, 53°-60°), and 5 kg (95% CI, 4-5 kg), respectively (P < .001), whereas external rotation at 0° (1°; 95% CI, -1° to 3°) did not improve (P = .4). The Constant score improved by 39 (95% CI, 38-41); Shoulder Pain and Disability Index, by 50 (95% CI, 47-52); and Subjective Shoulder Value, by 43 (95% CI, 41-45) (P < .001). Furthermore, the EQ-5D-5L index value improved by 0.31 (95% CI, 0.30-0.33), and the EQ-VAS score improved by 16 (95% CI, 14-18) (P < .001). Our case series showed a low complication rate with a consistent clinically relevant and statistically significant improvement across most clinical and patient-reported outcomes for the Univers Revers. Long-term safety requires further investigation.

Sections du résumé

BACKGROUND BACKGROUND
The use of reverse total shoulder arthroplasty (RTSA) has dramatically increased in recent years with the advent of new prosthesis designs regularly entering the market. We define the rate of local complications during the first 2 years after RTSA with the Univers Revers prosthesis and describe the changes in radiologic outcomes, as well as function, pain, satisfaction, and quality of life.
METHODS METHODS
This multicenter, prospective case series included rotator cuff tear arthropathy patients who underwent RTSA with the Univers Revers. Incidence percentages of complications and pathologic radiographic changes were documented. Mixed-model linear regression was used to examine changes in range of motion, shoulder function (Constant score, Shoulder Pain and Disability Index, Subjective Shoulder Value), and quality of life (EQ-5D-5L [European Quality of Life 5 Dimensions 5 Level] and EQ-VAS [EuroQol Visual Analog Scale]).
RESULTS RESULTS
Of 187 patients, 59.4% were women, and the mean age was 75.3 years (range, 56-91 years). Twenty-five percent of patients had a postoperative complication; 5 complications were severe (2.7%, 5 of 187), whereby 2 were implant related (1.1%; 95% confidence interval [CI], 0.1%-3.8%). The incidence of scapular notching was 10.6% (95% CI, 6.5%-16%). After 2 years, abduction, flexion, and abduction strength improved by 54° (95% CI, 50°-58°), 57° (95% CI, 53°-60°), and 5 kg (95% CI, 4-5 kg), respectively (P < .001), whereas external rotation at 0° (1°; 95% CI, -1° to 3°) did not improve (P = .4). The Constant score improved by 39 (95% CI, 38-41); Shoulder Pain and Disability Index, by 50 (95% CI, 47-52); and Subjective Shoulder Value, by 43 (95% CI, 41-45) (P < .001). Furthermore, the EQ-5D-5L index value improved by 0.31 (95% CI, 0.30-0.33), and the EQ-VAS score improved by 16 (95% CI, 14-18) (P < .001).
CONCLUSION CONCLUSIONS
Our case series showed a low complication rate with a consistent clinically relevant and statistically significant improvement across most clinical and patient-reported outcomes for the Univers Revers. Long-term safety requires further investigation.

Identifiants

pubmed: 32444315
pii: S1058-2746(20)30155-5
doi: 10.1016/j.jse.2020.01.090
pii:
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

2282-2291

Informations de copyright

Copyright © 2020 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Auteurs

Hans-Kaspar Schwyzer (HK)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland.

Alex Marzel (A)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland; Research, Teaching and Development, Schulthess Clinic, Zürich, Switzerland.

Barbara Wirth (B)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland.

Dominik Rickenbacher (D)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland; Research, Teaching and Development, Schulthess Clinic, Zürich, Switzerland.

Matthias Flury (M)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland.

Christian Schoch (C)

St. Vinzenz Clinic, Pfronten, Germany.

Mark Tauber (M)

Department of Shoulder and Elbow Surgery, ATOS Clinic, Munich, Germany; Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg, Austria.

Daniel Rzepka (D)

Trauma and Hand Surgery Clinic, Vincentius-Kliniken, Karlsruhe, Germany.

Lars Lehmann (L)

Trauma and Hand Surgery Clinic, Vincentius-Kliniken, Karlsruhe, Germany.

Sven Lichtenberg (S)

German Joint Center Heidelberg, ATOS Clinic, Heidelberg, Germany.

Petra Magosch (P)

Department of Shoulder and Elbow Surgery, ATOS Clinic, Munich, Germany; German Joint Center Heidelberg, ATOS Clinic, Heidelberg, Germany; Orthopedic and Trauma Surgery Center, University Medical Centre Mannheim, University of Heidelberg, Heidelberg, Germany.

Peter Habermeyer (P)

Department of Shoulder and Elbow Surgery, ATOS Clinic, Munich, Germany.

Laurent Audigé (L)

Shoulder and Elbow Surgery, Schulthess Clinic, Zürich, Switzerland; Research, Teaching and Development, Schulthess Clinic, Zürich, Switzerland. Electronic address: laurent.audige@kws.ch.

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Classifications MeSH