To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Euflexxa; Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT01895959
• Lead Sponsor: University of California, San Francisco

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

Not available

Study Timeline

• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Study Start: 2013-08
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2020-10
• Results First Submitted: 2020-10-26
• Results First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Results First Posted: 2020-11-18
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Euflexxa	Euflexxa	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	Magnetic Resonance Imaging (MRI)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy	3 months

Trial Locations

Locations (1)

UCSF - China Basin Imaging Center; 🇺🇸 San Francisco, California, United States