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Biochemical Changes in OA Knee After Euflexxa Injection
NCT01895959Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2013
- Primary completion
- Nov 2016
- Countries
- 1
- Sponsor
- University of California, San Francisco
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- sodium hyaluronate
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 4, open-label, single-arm trial of sodium hyaluronate in osteoarthritis (OA), sponsored by University of California, San Francisco. Primary endpoint: Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection at 3 months. Started Aug 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Euflexxa
Euflexxa intra-articular injection weekly for 3 weeks
03
Who it enrols
Patients 18-80 with symptomatic knee OA (KL grade I-III), pain >40mm, and knee effusion. Excludes BMI >40, recent knee surgery, prior viscosupplementation within 6 months, or steroid injections within 3 months.
04
Endpoints
Primary
Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
Secondary
Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy
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