PMID- 19083633
OWN - NLM
STAT- MEDLINE
DCOM- 20090331
LR  - 20220318
IS  - 1460-9584 (Electronic)
IS  - 1268-7731 (Linking)
VI  - 14
IP  - 3
DP  - 2008
TI  - A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 
      (Synvisc) in patients with symptomatic ankle (talo-crural) osteoarthritis.
PG  - 145-52
LID - 10.1016/j.fas.2008.01.001 [doi]
AB  - BACKGROUND: To evaluate the safety and efficacy of hylan G-F 20 in patients with 
      ankle osteoarthritis. METHODS: A prospective, open study in patients with 
      symptomatic (>or=50 mm and <or=90 mm on a 100 mm VAS) ankle osteoarthritis. 
      Patients received 1 ml x 2 ml intra-articular injection of hylan G-F 20, plus an 
      optional, second injection if pain remained at baseline levels after 1, 2 or 3 
      months. The primary efficacy endpoint was the change from baseline in the pain 
      VAS score at 3 months. RESULTS: Fifty-five patients received the first injection; 
      24 patients received a second. There were no serious or severe adverse events 
      (AEs) related to the treatment. Seventeen patients experienced mild or moderate 
      local, treatment-related AEs. The mean pain VAS score decreased from 68.0 mm 
      (baseline) to 33.8 mm at 3 months (p<0.001), which was maintained to 6 months 
      (34.2 mm, p<0.001). CONCLUSIONS: Hylan G-F 20 is well-tolerated and effective for 
      up to 6 months in the treatment of symptomatic ankle osteoarthritis.
FAU - Witteveen, Angelique G H
AU  - Witteveen AG
AD  - Orthopaedic Research Centre Amsterdam, Academic Medical Center, 1105 AZ 
      Amsterdam, The Netherlands. agh.witteveen@hotmail.com
FAU - Giannini, Sandro
AU  - Giannini S
FAU - Guido, Giulio
AU  - Guido G
FAU - Jerosch, Joerg
AU  - Jerosch J
FAU - Lohrer, Heinz
AU  - Lohrer H
FAU - Vannini, Francesca
AU  - Vannini F
FAU - Donati, Leonardo
AU  - Donati L
FAU - Schulz, Axel
AU  - Schulz A
FAU - Scholl, Jakob
AU  - Scholl J
FAU - Sierevelt, Inger N
AU  - Sierevelt IN
FAU - van Dijk, C Niek
AU  - van Dijk CN
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20080304
PL  - France
TA  - Foot Ankle Surg
JT  - Foot and ankle surgery : official journal of the European Society of Foot and 
      Ankle Surgeons
JID - 9609647
RN  - 0 (Viscosupplements)
RN  - 125935-84-4 (hylan)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adult
MH  - Ankle Joint/*physiopathology
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*analogs & derivatives/therapeutic use
MH  - Injections, Intra-Articular
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/physiopathology/*therapy
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Quality of Life
MH  - Viscosupplements/*therapeutic use
EDAT- 2008/12/17 09:00
MHDA- 2009/04/01 09:00
CRDT- 2008/12/17 09:00
PHST- 2007/07/10 00:00 [received]
PHST- 2007/11/20 00:00 [revised]
PHST- 2008/01/02 00:00 [accepted]
PHST- 2008/12/17 09:00 [entrez]
PHST- 2008/12/17 09:00 [pubmed]
PHST- 2009/04/01 09:00 [medline]
AID - S1268-7731(08)00002-7 [pii]
AID - 10.1016/j.fas.2008.01.001 [doi]
PST - ppublish
SO  - Foot Ankle Surg. 2008;14(3):145-52. doi: 10.1016/j.fas.2008.01.001. Epub 2008 Mar 
      4.