PMID- 18785414
OWN - NLM
STAT- MEDLINE
DCOM- 20081104
LR  - 20220318
IS  - 1071-1007 (Print)
IS  - 1071-1007 (Linking)
VI  - 29
IP  - 7
DP  - 2008 Jul
TI  - Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a 
      randomized, double-blind study for osteoarthritis of the ankle.
PG  - 657-63
AB  - BACKGROUND: The potential benefit of hyaluronans in alleviating pain associated 
      with osteoarthritis (OA) in joints other than the knee is of increasing interest. 
      This double-blind, randomized, controlled study examined the safety and efficacy 
      of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain 
      associated with ankle OA. MATERIALS AND METHODS: Thirty consecutive patients with 
      ankle OA documented by X-ray were randomized to treatment with five weekly 
      injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 
      mL (control) in the tibiotalar joint. The primary endpoint was pain on movement 
      and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after 
      injection (a 100-mm visual analog scale [VAS]). Additional measures included the 
      Western Ontario and McMaster Universities (WOMAC) OA Index and patient global 
      assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months 
      and 6 months; and all reported adverse events (AEs). RESULTS: The study groups 
      differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL 
      and 73% of the control patients completed the study. At Month 3, the primary 
      endpoint of the study, the HYL group demonstrated a significantly greater 
      improvement from baseline in AOS total score than did the control group (HYL: 
      -17.4 +/- 5.0 mm; CONTROL: -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was 
      low, with no significant differences between the groups. There were no 
      post-injection flares. CONCLUSION: Our study suggests that sodium hyaluronate may 
      be a safe and effective option for pain associated with ankle OA, although larger 
      studies are needed.
FAU - Cohen, Michael M
AU  - Cohen MM
AD  - Miami Veterans Affairs Medical Center, Surgical Service, 1201 NW 16th St, Miami, 
      FL 33125, USA. michael.cohen@med.va.gov
FAU - Altman, Roy D
AU  - Altman RD
FAU - Hollstrom, Richard
AU  - Hollstrom R
FAU - Hollstrom, Claire
AU  - Hollstrom C
FAU - Sun, Craig
AU  - Sun C
FAU - Gipson, Brad
AU  - Gipson B
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Foot Ankle Int
JT  - Foot & ankle international
JID - 9433869
RN  - 0 (Placebos)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Aged
MH  - *Ankle Joint
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/*therapeutic use
MH  - Injections, Intra-Articular
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/diagnostic imaging/*drug therapy
MH  - Pain Measurement
MH  - Pilot Projects
MH  - Placebos
MH  - Radiography
MH  - Safety
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
MH  - Weight-Bearing
EDAT- 2008/09/13 09:00
MHDA- 2008/11/05 09:00
CRDT- 2008/09/13 09:00
PHST- 2008/09/13 09:00 [pubmed]
PHST- 2008/11/05 09:00 [medline]
PHST- 2008/09/13 09:00 [entrez]
AID - 10.3113/FAI.2008.0657 [doi]
PST - ppublish
SO  - Foot Ankle Int. 2008 Jul;29(7):657-63. doi: 10.3113/FAI.2008.0657.