To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Euflexxa
Magnetic Resonance Imaging (MRI)
Sponsored by
About this trial
This is an interventional basic science trial for Knee Osteoarthritis focused on measuring knee osteoarthritis (OA), hyaluronic acid injection
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- UCSF - China Basin Imaging Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Euflexxa
Arm Description
EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Outcomes
Primary Outcome Measures
To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.
Secondary Outcome Measures
To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy
Full Information
NCT ID
NCT01895959
First Posted
July 5, 2013
Last Updated
October 26, 2020
Sponsor
University of California, San Francisco
Collaborators
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01895959
Brief Title
To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
Official Title
Quantifications of Biochemical Changes of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection Using Novel MRI (Magnetic Resonance Imaging) and NMR (Nuclear Magnetic Resonance) Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Ferring Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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) injection using high field NMR and MRI techniques.
We hypothesize that:
High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of glutamate will predict patient response of pain relief after HA injection;
MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and T2 will decrease in patients who respond to the treatment, indicating potential beneficial effects of HA injection to cartilage preservation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis (OA), hyaluronic acid injection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Euflexxa
Arm Type
Other
Arm Description
EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Intervention Type
Drug
Intervention Name(s)
Euflexxa
Other Intervention Name(s)
hyaluronic acid injection
Intervention Description
Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).
Primary Outcome Measure Information:
Title
To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
Description
The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojuan Li, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF - China Basin Imaging Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
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