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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00918736 |
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Date of registration:
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16/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
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Scientific title:
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Hyaluronans in the Treatment of Ankle Osteoarthritis |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00918736 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Shu-Fen Sun, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Veterans General Hospital, Kaohsiung, Taiwan |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Drug: sodium hyaluronate
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Primary Outcome(s)
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Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
[Time Frame: baseline and 6 months]
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Secondary Outcome(s)
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The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
[Time Frame: 6 months]
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the Level of Global Satisfaction Based on a 7-Point Categorical Scale
[Time Frame: 6 months]
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Rescue Acetaminophen Consumption
[Time Frame: 6 months]
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Ankle Sagittal Range of Motion
[Time Frame: 6 months]
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Four Clinical Balance Tests
[Time Frame: 6 months]
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Systemic and Local Adverse Events Recording
[Time Frame: 6 months]
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Secondary ID(s)
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NSC96-2314-B-075B-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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