Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial.
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
pubmed:
15
11
2022
medline:
22
12
2022
entrez:
14
11
2022
Statut:
ppublish
Résumé
End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). To determine which treatment is superior in terms of clinical scores and adverse events. A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307). 17 National Health Service trusts across the United Kingdom. Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure. Patients were randomly assigned to TAR or AF surgical treatment. The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible. Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]). Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques. Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%. National Institute for Health and Care Research Heath Technology Assessment Programme.
Sections du résumé
BACKGROUND
End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF).
OBJECTIVE
To determine which treatment is superior in terms of clinical scores and adverse events.
DESIGN
A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307).
SETTING
17 National Health Service trusts across the United Kingdom.
PATIENTS
Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure.
INTERVENTION
Patients were randomly assigned to TAR or AF surgical treatment.
MEASUREMENTS
The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible.
RESULTS
Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]).
LIMITATION
Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques.
CONCLUSION
Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%.
PRIMARY FUNDING SOURCE
National Institute for Health and Care Research Heath Technology Assessment Programme.
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1648-1657Investigateurs
Rick Brown
(R)
Michael Butler
(M)
Carolyn Chadwick
(C)
Tim Clough
(T)
Nick Cullen
(N)
Mark Davies
(M)
Howard Davies
(H)
Bill Harries
(B)
Michael Khoo
(M)
Nilesh Makwana
(N)
An Murty
(A)
Ali Najefi
(A)
Paul O'Donnell
(P)
Martin Raglan
(M)
Rhys Thomas
(R)
Paulo Torres
(P)
Matthew Welck
(M)
Ian Winson
(I)
Razi Zaidi
(R)
Stephen Bendall
(S)
Ekaterina Bordea
(E)
Andrew Bing
(A)
Chris Blundell
(C)
Kashfia Chowdhury
(K)
Paul Cooke
(P)
Sunil Dhar
(S)
Caroline Doré
(C)
Andrew Goldberg
(A)
Paul Halliwell
(P)
Steve Hepple
(S)
Mike Karski
(M)
David T Loveday
(DT)
Steve Milner
(S)
Viren Mishra
(V)
Andrew Molloy
(A)
Simon Skene
(S)
Malik Siddique
(M)
David Townshend
(D)
Simon Hill
(S)
Chris Marquis
(C)
Jayasree Ramaskandhan
(J)
Mark Rogers
(M)
Anthony Sakellariou
(A)
George Smith
(G)
Robert Smith
(R)
Matt Solan
(M)
Commentaires et corrections
Type : CommentIn
Type : ErratumIn
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