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VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years

BACKGROUND: Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes. MATERIALS AND METHODS: A single-centre randomized co...

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Autores principales: Thorninger, Rikke, Wæver, Daniel, Tjørnild, Michael, Lind, Martin, Rölfing, Jan Duedal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9705678/
https://www.ncbi.nlm.nih.gov/pubmed/36443579
http://dx.doi.org/10.1186/s10195-022-00673-4
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author Thorninger, Rikke
Wæver, Daniel
Tjørnild, Michael
Lind, Martin
Rölfing, Jan Duedal
author_facet Thorninger, Rikke
Wæver, Daniel
Tjørnild, Michael
Lind, Martin
Rölfing, Jan Duedal
author_sort Thorninger, Rikke
collection PubMed
description BACKGROUND: Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes. MATERIALS AND METHODS: A single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting. Primary outcome: complications assessed after 2 and 5 weeks and 6 and 12 months. Secondary outcomes: Quick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L. RESULTS: 148 patients were screened from November 2019 to March 2021. 48 patients did not want to participate or were unable to participate in the follow-up. 100 patients were randomized and 85 patients were available for full analysis due to there being 4 deaths, 6 withdrawals, 1 wrong inclusion, 1 emigration, 1 refracture, 1 patient with compartment syndrome, and 1 who was advised to undergo surgery after being randomized to non-operative treatment. Median age was 74 years (range 65–92), 81 women/19 men, 42 right/58 left side, 87 retired, 11 smokers, 86 ASA class 1 or 2. Complication rates did not statistical significantly vary between the operative and non-operative group: 20.9% (9/43) vs 16.6% (7/42), p = 0.78 (Fisher’s exact test). Complications were driven by sensory disturbances. Four reoperations were performed: two in the non-operative group: carpal tunnel syndrome; two in the operative group: one carpal tunnel syndrome, one protruding screw causing extensor tendon irritation. Mean difference in Quick-DASH varied from 2.3 (95% CI − 3 to 8) pre-injury to 4.2 (− 4 to 12) at 12 months. Quick-DASH and PRWHE were neither statistically nor clinically-relevant different between groups. CONCLUSIONS: Complication rates after operative and non-operative treatment of DRF were similar. Volar plating did not improve the functional outcome after 5 weeks, 6 months, and 12 months. These findings are in line with recent RCTs and mandate a revision of guidelines towards more conservative treatment. Take home messages: (1) consider non-operative treatment in elderly patients sustaining unstable DRFs; (2) choosing operative treatment in patients older than 65 years should not be the gold standard; (3) however, non-operative treatment still carries a risk for complications. LEVEL OF EVIDENCE: II. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306.
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spelling pubmed-97056782022-11-29 VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years Thorninger, Rikke Wæver, Daniel Tjørnild, Michael Lind, Martin Rölfing, Jan Duedal J Orthop Traumatol Original Article BACKGROUND: Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes. MATERIALS AND METHODS: A single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting. Primary outcome: complications assessed after 2 and 5 weeks and 6 and 12 months. Secondary outcomes: Quick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L. RESULTS: 148 patients were screened from November 2019 to March 2021. 48 patients did not want to participate or were unable to participate in the follow-up. 100 patients were randomized and 85 patients were available for full analysis due to there being 4 deaths, 6 withdrawals, 1 wrong inclusion, 1 emigration, 1 refracture, 1 patient with compartment syndrome, and 1 who was advised to undergo surgery after being randomized to non-operative treatment. Median age was 74 years (range 65–92), 81 women/19 men, 42 right/58 left side, 87 retired, 11 smokers, 86 ASA class 1 or 2. Complication rates did not statistical significantly vary between the operative and non-operative group: 20.9% (9/43) vs 16.6% (7/42), p = 0.78 (Fisher’s exact test). Complications were driven by sensory disturbances. Four reoperations were performed: two in the non-operative group: carpal tunnel syndrome; two in the operative group: one carpal tunnel syndrome, one protruding screw causing extensor tendon irritation. Mean difference in Quick-DASH varied from 2.3 (95% CI − 3 to 8) pre-injury to 4.2 (− 4 to 12) at 12 months. Quick-DASH and PRWHE were neither statistically nor clinically-relevant different between groups. CONCLUSIONS: Complication rates after operative and non-operative treatment of DRF were similar. Volar plating did not improve the functional outcome after 5 weeks, 6 months, and 12 months. These findings are in line with recent RCTs and mandate a revision of guidelines towards more conservative treatment. Take home messages: (1) consider non-operative treatment in elderly patients sustaining unstable DRFs; (2) choosing operative treatment in patients older than 65 years should not be the gold standard; (3) however, non-operative treatment still carries a risk for complications. LEVEL OF EVIDENCE: II. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306. Springer International Publishing 2022-11-28 2022-12 /pmc/articles/PMC9705678/ /pubmed/36443579 http://dx.doi.org/10.1186/s10195-022-00673-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Thorninger, Rikke
Wæver, Daniel
Tjørnild, Michael
Lind, Martin
Rölfing, Jan Duedal
VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title_full VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title_fullStr VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title_full_unstemmed VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title_short VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
title_sort volcon: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9705678/
https://www.ncbi.nlm.nih.gov/pubmed/36443579
http://dx.doi.org/10.1186/s10195-022-00673-4
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