Status:
COMPLETED
To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to identify novel imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after intra-articular HA (Euflexxa) ...
Eligibility Criteria
Inclusion
- Age 18 to 80 years
- Symptomatic knee OA as defined by the American College of Rheumatology criteria
- Kellgren-Lawrence grade I, II or III on prior x-rays (take within 6 months of screening visit)
- knee pain score \>40 mm on a 100 mm visual analogue scale for \> 15 days in the last month
- NSAIDs permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
- Have been recommended for Euflexxa treatment by physician
- Knee effusion based on clinical exam or imaging
Exclusion
- Any contraindication to MRI (pregnancy, metallic fragments in the eyes, vascular clips, Pacemakers etc)
- History of knee replacement
- Known sensitivity or allergy to any component of Euflexxa
- Inflammatory arthritis
- Previously received viscosupplementation therapy within 6 months of study enrollment
- Intra-articular injection of corticosteroid to study joint within the past 3 months
- Arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
- Concomitant medications of oral/parenteral corticosteroids
- Morbid obesity defined as body mass index (BMI) \>40 kg/m2
- Active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
- Large knee effusion based on clinical exam or imaging
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01895959
Start Date
August 1 2013
End Date
January 1 2017
Last Update
November 18 2020
Active Locations (1)
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1
UCSF - China Basin Imaging Center
San Francisco, California, United States, 94107