Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study.
OBJECTIVE
To investigate the efficacy, safety and the duration of treatment effectiveness of intra-articular hyaluronic acid (Artz, Japan) in patients with ankle osteoarthritis (OA).


METHODS
As a prospective clinical trial, 93 patients with unilateral ankle pain for at least 6 months and radiographically classified as Kellgren-Lawrence grade I or II ankle OA were included. After five weekly intra-articular Artz injections, the Ankle Osteoarthritis Scale (AOS), the American Orthopaedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, ankle sagittal range of motion (ROM), patients' global satisfaction, local adverse events and consumption of rescue analgesics were analyzed.


RESULTS
Seventy-five patients completed the study. Significant improvement in AOS and AOFAS ankle/hindfoot scores was noted at 1 week, 1 month, 3 months and 6 months post the fifth injection (P < 0.001 compared with baseline). The mean reduction of AOS score was 1.9, 2.6, 2.5 and 2.6 at each following visit (P < 0.001). The mean AOFAS ankle/hindfoot score improved from 64 points at baseline to 75, 78, 78, and 78 points at 1 week, 1 month, 3 months and 6 months, respectively, post the fifth injection (P < 0.001). Ankle sagittal ROM did not improve significantly (P > 0.05). The majority of patients reported satisfaction at 1 week (100%), 1 month (100%), 3 months (90.7%) and 6 months (86.7%) follow-up. Local adverse events occurred in 6.7% of patients. Acetaminophen consumption dropped significantly following treatment (P < 0.001).


CONCLUSIONS
Five weekly intra-articular injections of Artz provide pain relief and functional improvements in patients with Kellgren-Lawrence grades I and II ankle OA. The clinical effect was rapid at 1 week and may last for 6 months or more.
Sun
Shu-Fen
SF
Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan. sfsun.tw@@yahoo.com.tw
Chou
Yi-Jiun
YJ
Hsu
Chien-Wei
CW
Hwang
Chiao-Wen
CW
Hsu
Pei-Te
PT
Wang
Jue-Long
JL
Hsu
Ya-Wen
YW
Chou
Mei-Chia
MC
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000627:therapeutic use; D000328:Adult; D000843:Ankle Joint / Q000503:physiopathology; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000627:therapeutic use; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D006820:Hyaluronic Acid