Phase 2
N=50
Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00918736 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months — 2.3 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sodium hyaluronate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kaohsiung Veterans General Hospital.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months |
2.3 | <0.05 sig |
| SECONDARY The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score |
— | — |
| SECONDARY Ankle Sagittal Range of Motion |
— | — |
| SECONDARY Four Clinical Balance Tests |
— | — |
| SECONDARY the Level of Global Satisfaction Based on a 7-point Categorical Scale |
— | — |
| SECONDARY Systemic and Local Adverse Events Recording |
— | — |
| SECONDARY Rescue Acetaminophen Consumption |
— | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00918736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.