Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis (OA), hyaluronic acid injection
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: 1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection; 2. 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; 3. 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.
Interventions
DRUGEuflexxa
Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
DEVICEMagnetic Resonance Imaging (MRI)
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).
Sponsors
Ferring Pharmaceuticals
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection | 3 months | 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
| Measure | Time frame |
|---|---|
| To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy | 3 months |
Other
| Measure | Time frame |
|---|---|
| To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects treated with Euflexxa | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 59.17 years STANDARD_DEVIATION 9.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 3 months
Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.
Secondary
To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy
Time frame: 3 months
Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.
Other Pre-specified
To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI
Time frame: 3 months
Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.