Fixation Using Alternative Implants for the Treatment of Hip Fractures: The feasibility of a multicenter 2 × 2 factorial randomized controlled trial evaluating surgical treatment and vitamin D supplementation in young femoral neck fracture patients.
clinical protocols
femoral neck fractures
fracture fixation
internal
randomized controlled trial
vitamin D
Journal
OTA international : the open access journal of orthopaedic trauma
ISSN: 2574-2167
Titre abrégé: OTA Int
Pays: United States
ID NLM: 101770383
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
06
08
2019
accepted:
15
12
2019
entrez:
3
5
2021
pubmed:
4
5
2021
medline:
4
5
2021
Statut:
epublish
Résumé
To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Pilot trial. Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.
Identifiants
pubmed: 33937697
doi: 10.1097/OI9.0000000000000066
pii: OTAI-D-19-00042
pmc: PMC8022909
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e066Informations de copyright
Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association.
Références
World J Orthop. 2014 Jul 18;5(3):204-17
pubmed: 25035822
Injury. 2017 Aug;48(8):1837-1842
pubmed: 28651782
Menopause. 2012 Jan;19(1):89-95
pubmed: 21934533
Arch Gerontol Geriatr. 2009 Nov-Dec;49(3):364-7
pubmed: 19147237
BMC Med Res Methodol. 2010 Jan 06;10:1
pubmed: 20053272
Climacteric. 2010 Dec;13(6):578-84
pubmed: 19951084
Lancet. 2017 Apr 15;389(10078):1519-1527
pubmed: 28262269
Drugs Aging. 2009;26(10):861-9
pubmed: 19761279
Pilot Feasibility Stud. 2019 May 28;5:70
pubmed: 31161044
J Bone Joint Surg Br. 1997 Mar;79(2):254-7
pubmed: 9119852
J Bone Joint Surg Am. 2017 Jul 5;99(13):1086-1092
pubmed: 28678121
Korean J Anesthesiol. 2017 Dec;70(6):601-605
pubmed: 29225742
J Orthop Trauma. 2013 Mar;27(3):177-81
pubmed: 23449099
Pilot Feasibility Stud. 2019 Nov 22;5:135
pubmed: 31768262
Control Clin Trials. 2003 Dec;24(6):719-25
pubmed: 14662277
Injury. 2021 Feb 14;:
pubmed: 33618847
S Afr Med J. 2018 Oct 26;108(11):917-921
pubmed: 30645956
BMJ. 2016 Oct 24;355:i5239
pubmed: 27777223