N/A
N=24
Euflexxa for the Treatment of Osteoarthritis
Osteo Arthritis Knee
Bottom Line
View on ClinicalTrials.gov: NCT03459365 ↗Enrolled (actual)
24
Serious AEs
10.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Hyaluronate Concentration — 0.29568 mg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Euflexxa (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hyaluronate Concentration |
0.29568 | — |
| SECONDARY Changes in Tumor Necrosis Factor-stimulated Gene 6 (TSG-6) |
3450 | — |
| SECONDARY VAS Pain Score Improvement |
40 | — |
Summary
The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and degenerative synovial fluid bio-markers in patients with knee osteoarthritis
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03459365). 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.