Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments euflexxa, magnetic resonance imaging (mri)
Phase phase 4
Sponsor University of California, San Francisco
Collaborator Ferring Pharmaceuticals
Start date August 2013
End date November 2016
Trial size 12 participants
Trial identifier NCT01895959, Ferring-Euflexxa

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Other)
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.
euflexxa hyaluronic acid injection
Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
magnetic 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).

Primary Outcomes

Measure
To identify imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage in knee OA after HA injection
time frame: 3 months

Secondary Outcomes

Measure
To quantify synovial fluid biochemical changes using high field HRMAS NMR spectroscopy
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Xiaojuan Li, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.