Status:
COMPLETED
Euflexxa for the Treatment of Osteoarthritis
Lead Sponsor:
The Cleveland Clinic
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and degenerative synovial fluid bio-markers in patients with knee osteoarthritis
Detailed Description
The FLEXX trial was the first well-controlled, randomized, double-blind, multicenter study evaluating the efficacy of Euflexxa (1% sodium hyaluronate) therapy for knee osteoarthritis. Five-hundred-and...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- OA of the knee by American College of Rheumatology criteria
- Those who failed non-pharmacological measures or simple analgesics
- moderate to severe pain score of 41 to 90 mm recorded on 100-mm visual analog scale (VAS) immediately following a 50-foot walk
- bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3 OA of the target knee
- ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- unassisted walking 50 feet on a flat surface and going up and down stairs
- willingness and ability to complete efficacy and safety questionnaires
- Exclusion criteria:
- Age less than 18 years
- any major injury to the target knee within the prior 12 months
- any surgery to the target knee within the prior 12 months
- surgery to the contralateral knee or other weight-bearing
- inflammatory arthropathies
- gout or pseudogout within the previous 6 months
- radiographic acute fracture, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
- osteonecrosis of either knee
- fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
- target knee joint infection or skin disorder/ infection within the previous 6 months
- symptomatic OA of the hips, spine, or ankle; known hypersensitivity to acetaminophen, IA-BioHA, or phosphate-buffered saline solution
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the study
- history of immune disorders; vascular insufficiency of lower limbs or peripheral neuropathy
- current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
- active liver or renal disease
- any clinically significant abnormal laboratory value \[to be defined in detail at a later point\]
- any intercurrent chronic disease or condition that might interfere with the completion of the study
- participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month
Exclusion
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03459365
Start Date
July 9 2018
End Date
October 31 2021
Last Update
September 4 2024
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195