Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis (OA) hyaluronic acid injection
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Euflexxa intervention 2: Magnetic Resonance Imaging (MRI)
Intervention descriptions: intervention 1: Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint. intervention 2: 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).

Protocol document: