Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury.
Clinical trial
Considerations
Injury
Knee
Osteoarthritis
Outcome
Journal
Osteoarthritis and cartilage
ISSN: 1522-9653
Titre abrégé: Osteoarthritis Cartilage
Pays: England
ID NLM: 9305697
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
11
01
2018
revised:
17
07
2018
accepted:
06
08
2018
pubmed:
21
8
2018
medline:
17
3
2020
entrez:
21
8
2018
Statut:
ppublish
Résumé
There are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury. An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors. The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies. These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.
Identifiants
pubmed: 30125638
pii: S1063-4584(18)31412-2
doi: 10.1016/j.joca.2018.08.001
pmc: PMC6323612
pii:
doi:
Types de publication
Consensus Development Conference
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
23-33Subventions
Organisme : Arthritis Research UK
ID : 21621
Pays : United Kingdom
Organisme : Arthritis Research UK
ID : 20781
Pays : United Kingdom
Organisme : NIAMS NIH HHS
ID : P50 AR060752
Pays : United States
Organisme : Arthritis Research UK
ID : 21595
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_16041
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S016538/1
Pays : United Kingdom
Organisme : NIAMS NIH HHS
ID : P30 AR072571
Pays : United States
Organisme : Versus Arthritis
ID : 21509
Pays : United Kingdom
Organisme : Arthritis Research UK
ID : 20205
Pays : United Kingdom
Organisme : Versus Arthritis
ID : 21076
Pays : United Kingdom
Investigateurs
J Adams
(J)
M Blank
(M)
M Batt
(M)
P Biggs
(P)
M Busse-Morris
(M)
K Button
(K)
J Calder
(J)
J Cook
(J)
C Edwards
(C)
E Fisheleva
(E)
D F Hamilton
(DF)
H Harrison
(H)
C Holt
(C)
M Jones
(M)
R Jones
(R)
S Kluzek
(S)
T Knight
(T)
G Nuki
(G)
S Parekh
(S)
G Peat
(G)
C Pothet
(C)
T Rainer
(T)
N Robinson
(N)
L Sawle
(L)
T Vincent
(T)
A Williams
(A)
E Wise
(E)
W Zhang
(W)
S Bierma-Zeinstra
(S)
Informations de copyright
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
Références
Osteoarthritis Cartilage. 2016 Jul;24(7):1180-9
pubmed: 26850823
Ann Rheum Dis. 2015 Jan;74(1):242-51
pubmed: 24130267
Arthritis Rheumatol. 2015 Jul;67(7):1816-25
pubmed: 25914389
Am J Sports Med. 2017 Apr;45(5):1075-1084
pubmed: 28768432
Knee. 2003 Mar;10(1):93-6
pubmed: 12649034
Arthritis Rheumatol. 2016 Sep;68(9):2129-40
pubmed: 26991527
Am J Sports Med. 2017 Feb;45(2):325-333
pubmed: 28146402
Scand J Med Sci Sports. 2007 Apr;17(2):109-14
pubmed: 17394470
BMJ. 2013 Jan 24;346:f232
pubmed: 23349407
J Arthroplasty. 2016 Oct;31(10):2108-14
pubmed: 27181491
Arthritis Rheum. 1993 Sep;36(9):1214-22
pubmed: 8216415
Arthritis Rheum. 1998 Jul;41(7):1266-74
pubmed: 9663485
Radiology. 2012 Aug;264(2):531-41
pubmed: 22692033
Semin Arthritis Rheum. 2018 Feb;47(4):457-463
pubmed: 28917712
J Orthop Trauma. 2006 Nov-Dec;20(10):739-44
pubmed: 17106388
Osteoarthritis Cartilage. 2016 Feb;24(2):270-3
pubmed: 26318660
Arthritis Rheum. 2007 Aug;56(8):2523-34
pubmed: 17665433
Osteoarthritis Cartilage. 2017 Sep;25(9):1443-1451
pubmed: 28522220
Rheumatology (Oxford). 2016 Feb;55(2):320-6
pubmed: 26361882
Arthritis Rheum. 2004 Aug;50(8):2539-46
pubmed: 15334468
Am J Sports Med. 2012 Feb;40(2):276-85
pubmed: 21952715
Osteoarthritis Cartilage. 2013 Aug;21(8):1009-24
pubmed: 23685095
Curr Drug Targets. 2007 Feb;8(2):367-76
pubmed: 17305514
Am J Sports Med. 2014 Sep;42(9):2193-8
pubmed: 25035175
Osteoarthritis Cartilage. 2011 May;19(5):500-8
pubmed: 21396470
Contemp Clin Trials. 2007 May;28(3):295-302
pubmed: 17137844
J Orthop Res. 2017 Mar;35(3):718-729
pubmed: 27563836
Osteoarthritis Cartilage. 2015 May;23(5):747-60
pubmed: 25952346
Arthritis Rheumatol. 2019 Feb;71(2):238-243
pubmed: 30079991
Matrix Biol. 1999 Jun;18(3):225-37
pubmed: 10429942
J Orthop Res. 2015 Sep;33(9):1266-77
pubmed: 25939531
Osteoarthritis Cartilage. 2014 Oct;22(10):1429-43
pubmed: 25278054
Osteoarthritis Cartilage. 2014 May;22(5):668-82
pubmed: 24657830
Knee Surg Sports Traumatol Arthrosc. 2015 Oct;23(10):2805-13
pubmed: 25763847
Osteoarthritis Cartilage. 2012 Jan;20(1):13-21
pubmed: 22044841
J Orthop Res. 2017 Mar;35(3):641-650
pubmed: 27279368
Ann Rheum Dis. 2008 Dec;67(12):1716-23
pubmed: 18541604
Am J Sports Med. 2016 Jun;44(6):1524-33
pubmed: 26965680
Osteoarthritis Cartilage. 2016 Nov;24(11):1890-1897
pubmed: 27374877
Am J Sports Med. 2006 Sep;34(9):1512-32
pubmed: 16905673
Osteoarthritis Cartilage. 2015 May;23(5):674-6
pubmed: 25952340
Osteoarthritis Cartilage. 2012 Apr;20(4):271-8
pubmed: 22273632
Pain. 2000 May;86(1-2):69-74
pubmed: 10779662
Am J Sports Med. 2018 Mar;46(4):890-899
pubmed: 29364702
Osteoarthritis Cartilage. 2009 Feb;17(2):161-7
pubmed: 18760637
Osteoarthritis Cartilage. 2014 Jul;22(7):959-68
pubmed: 24867633
Osteoarthritis Cartilage. 2015 May;23(5):677-85
pubmed: 25952341
Osteoarthritis Cartilage. 2011 Aug;19(8):990-1002
pubmed: 21645627
Osteoarthritis Cartilage. 2015 May;23(5):815-25
pubmed: 25952352
Drugs Aging. 2015 Jul;32(7):525-35
pubmed: 26085027
Am J Sports Med. 2007 Oct;35(10):1756-69
pubmed: 17761605
Arthritis Rheum. 2003 Nov;48(11):3130-9
pubmed: 14613275