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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 February 2015 |
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Main ID: |
NCT01185444 |
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Date of registration:
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13/08/2010 |
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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 Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)
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Scientific title:
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Efficacy of 3 Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Physical Function in Patients With Knee Osteoarthritis—a Randomized Controlled Clinical Trial |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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89 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01185444 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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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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Jue-Long Wang, 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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Kaohsiung Veterans General Hospital, Taiwan |
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Name:
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Hsien-Pin 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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Cheng Ching Hospital, Taiwan |
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Name:
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Hung-Ju Li, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Statistics, National University of Kaohsiung, Taiwan |
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Name:
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Chien-Wei Hsu, 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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Department of Internal Medicine, Kaohsiung Veterans General Hospital |
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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;National Yang-Ming University School of Medicine, Taiwan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- (1) age 40 years or older, presence of a primary knee OA with knee pain for at least
6 months despite conservative treatment (rest, physical therapy, orthoses or pain
medications etc.); (2) had average pain on knee movement of at least 3 cm on a 10-cm
VAS; (3) had a current Lequesne index score (described below) >7 (possible range,
0-24); (4) were willing to discontinue all nonsteroidal anti-inflammatory drugs
(NSAIDs) or other analgesic medication (except for rescue medication) for the
duration of the study; and (5) were willing to not receive physical therapy or trial
of shoe modifications or orthoses during the study period.
Exclusion Criteria:Exclusion criteria included previous orthopedic surgery on the spine or
lower limbs, knee instability or marked deformity on examination, clinically apparent
tense effusion of the knee, intra-articular steroid or HA injection in any joint within
the past 6 months, and concomitant inflammatory arthropathy or other rheumatologic,
neurological, cardiovascular or psychiatric disorders that would interfere with the
clinical assessment during the study period.
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Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyaluronate
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Osteoarthritis
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Knee
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Intervention(s)
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Procedure: Hyalgan
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Procedure: Hya-Joint
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Primary Outcome(s)
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visual analog scale
[Time Frame: 6 months after the third injection]
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Secondary Outcome(s)
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Timed " Up-and-Go" test
[Time Frame: 6 months after the third injection.]
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Lequesne index
[Time Frame: 6 months after the third injection]
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the level of global satisfaction
[Time Frame: 6 months after the third injection.]
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Secondary ID(s)
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VGHKS97-CT9-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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