Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.
• Collaborator: National Science Council, Taiwan
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications

• ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22

• had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)

• were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane

• were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study

• did not receive physical therapy or trial of shoe modifications or orthotics during the study period

Exclusion Criteria:

• pregnant and lactating women

• bilateral ankle OA requiring treatment of both ankles

• chronic ankle instability

• lower leg trauma other than within the ankle

• previous orthopedic surgery on the spine, hip or knee

• presence of active joint infections of foot or ankle

• previous surgery or arthroscopy on the ankle within 12 months

• intraarticular steroid or HA injection in the treated ankle within the past 6 months

• treatment with anticoagulants or immunosuppressives

• history of rheumatoid arthritis, gout, or any other inflammatory arthropathy

• history of avian protein allergy

• presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study