PMID- 24185114
OWN - NLM
STAT- MEDLINE
DCOM- 20140908
LR  - 20220409
IS  - 1522-9653 (Electronic)
IS  - 1063-4584 (Linking)
VI  - 22
IP  - 1
DP  - 2014 Jan
TI  - NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a 
      prospective, multi-centre, randomized, non-inferiority trial.
PG  - 17-25
LID - S1063-4584(13)00982-5 [pii]
LID - 10.1016/j.joca.2013.10.009 [doi]
AB  - OBJECTIVE: To compare NASHA hyaluronic acid gel as single-injection 
      intra-articular (IA) treatment for knee osteoarthritis (OA) against 
      methylprednisolone acetate (MPA). DESIGN: This was a prospective, multi-centre, 
      randomized, active-controlled, double-blind, non-inferiority clinical trial. A 
      unique, open-label extension phase (OLE) was undertaken to answer further 
      important clinical questions. Subjects with painful unilateral knee OA were 
      treated and followed for 26 weeks (blinded phase). All patients attending the 
      clinic at 26 weeks were offered NASHA treatment, with a subsequent 26-week 
      follow-up period (extension phase). The primary objective was to show 
      non-inferiority of NASHA vs MPA in Western Ontario and McMaster Universities 
      Osteoarthritis Index (WOMAC) pain responder rate (percentage of patients with 
      >/=40% improvement from baseline in WOMAC pain score and an absolute improvement of 
      >/=5 points) at 12 weeks. RESULTS: In total, 442 participants were enrolled. The 
      primary objective was met, with NASHA producing a non-inferior response rate vs 
      MPA at 12 weeks (NASHA: 44.6%; MPA: 46.2%; difference [95% CI]: 1.6% [-11.2%; 
      +7.9%]). Effect size for WOMAC pain, physical function and stiffness scores 
      favoured NASHA over MPA from 12 to 26 weeks. In response to NASHA treatment at 26 
      weeks, sustained improvements were seen in WOMAC outcomes irrespective of initial 
      treatment. No serious device-related adverse events (AEs) were reported. 
      CONCLUSIONS: This study shows that single-injection NASHA was well tolerated and 
      non-inferior to MPA at 12 weeks. The benefit of NASHA was maintained to 26 weeks 
      while that of MPA declined. An injection of NASHA at 26 weeks conferred long-term 
      improvements without increased sensitivity or risk of complications. STUDY 
      IDENTIFIER: NCT01209364 (www.clinicaltrials.gov).
CI  - Copyright (c) 2013 Osteoarthritis Research Society International. Published by 
      Elsevier Ltd. All rights reserved.
FAU - Leighton, R
AU  - Leighton R
AD  - QEII Health Sciences Centre, New Halifax Infirmary, Halifax, NS, Canada. 
      Electronic address: r.k.leighton@ns.sympatico.ca.
FAU - Akermark, C
AU  - Akermark C
AD  - Sport Med, Birger Jarlsgatan 106A, SE-11420 Stockholm, Sweden.
FAU - Therrien, R
AU  - Therrien R
AD  - Centre de Rhumatologie St-Louis, Saint-Foy, Quebec, Canada G1W4R4.
FAU - Richardson, J B
AU  - Richardson JB
AD  - Robert Jones and Agnes Hunt Orthopaedic & District Hospital, Institute of 
      Orthopaedics Oswestry, SY10 7AG, UK.
FAU - Andersson, M
AU  - Andersson M
AD  - Q-Med AB, Seminariegatan 21, 752 28 Uppsala, Sweden.
FAU - Todman, M G
AU  - Todman MG
AD  - Smith & Nephew UK Ltd, Research Centre, York Science Park, York, UK.
FAU - Arden, N K
AU  - Arden NK
AD  - NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, UK.
CN  - DUROLANE Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01209364
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20131101
PL  - England
TA  - Osteoarthritis Cartilage
JT  - Osteoarthritis and cartilage
JID - 9305697
RN  - 0 (Glucocorticoids)
RN  - 43502P7F0P (Methylprednisolone Acetate)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Female
MH  - Glucocorticoids/adverse effects/*therapeutic use
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/adverse effects/*therapeutic use
MH  - Injections, Intra-Articular
MH  - Male
MH  - Methylprednisolone/adverse effects/*analogs & derivatives/therapeutic use
MH  - Methylprednisolone Acetate
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pain Measurement/methods
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Knee
OT  - Methylprednisolone acetate
OT  - NASHA hyaluronic acid gel
OT  - Osteoarthritis
FIR - Therrien, Rene
IR  - Therrien R
FIR - Bell, Mary
IR  - Bell M
FIR - Thorne, Carter
IR  - Thorne C
FIR - Bensen, William
IR  - Bensen W
FIR - Cividino, Alfred
IR  - Cividino A
FIR - Olszynski, Woijciech
IR  - Olszynski W
FIR - Khraishi, Majed
IR  - Khraishi M
FIR - Dobson, Crawford
IR  - Dobson C
FIR - Leighton, Ross
IR  - Leighton R
FIR - Werle, Jason
IR  - Werle J
FIR - Alleyne, Julia
IR  - Alleyne J
FIR - Litchfield, Robert
IR  - Litchfield R
FIR - Stanish, William
IR  - Stanish W
FIR - Chow, Andrew
IR  - Chow A
FIR - Wilson, Diane
IR  - Wilson D
FIR - Arden, Nigel
IR  - Arden N
FIR - Birrel, Fraser
IR  - Birrel F
FIR - Richardson, James
IR  - Richardson J
FIR - Scott, David
IR  - Scott D
FIR - Akermark, Christian
IR  - Akermark C
FIR - Isacson, Johan
IR  - Isacson J
FIR - Ericsater, Jan
IR  - Ericsater J
FIR - Adalberth, Torsten
IR  - Adalberth T
FIR - Melberg, Per-Erik
IR  - Melberg PE
EDAT- 2013/11/05 06:00
MHDA- 2014/09/10 06:00
CRDT- 2013/11/05 06:00
PHST- 2013/04/26 00:00 [received]
PHST- 2013/10/11 00:00 [revised]
PHST- 2013/10/22 00:00 [accepted]
PHST- 2013/11/05 06:00 [entrez]
PHST- 2013/11/05 06:00 [pubmed]
PHST- 2014/09/10 06:00 [medline]
AID - S1063-4584(13)00982-5 [pii]
AID - 10.1016/j.joca.2013.10.009 [doi]
PST - ppublish
SO  - Osteoarthritis Cartilage. 2014 Jan;22(1):17-25. doi: 10.1016/j.joca.2013.10.009. 
      Epub 2013 Nov 1.