Status:
COMPLETED
Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Conditions:
Hyaluronate
Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with kne...
Detailed Description
Background: Viscosupplementation with intra-articular hyaluronate injections is a safe and effective treatment of knee osteoarthritis. There are several forms of hyaluronate with different origin, met...
Eligibility Criteria
Inclusion
- (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
- 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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Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01185444
Start Date
February 1 2009
End Date
December 1 2009
Last Update
August 20 2010
Active Locations (1)
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1
Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
Kaohsiung City, Taiwan, 813