Clinical trial NCT01895959: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis (OA)
hyaluronic acid injection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2013-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection
timeFrame: 3 months
Secondary outcomes:
measure: To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy
timeFrame: 3 months
Other outcomes:
measure: To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI
timeFrame: 3 months
Locations:
city: San Francisco
country: United States
facility: UCSF - China Basin Imaging Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Xiaojuan Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: