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

NCT ID: NCT01895959

Last Updated: 2020-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-01-31

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis (OA); hyaluronic acid injection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Euflexxa

Intervention Type: DRUG

Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

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).

Interventions

Euflexxa

Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.

Intervention Type: DRUG

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).

Intervention Type: DEVICE

Other Intervention Names

hyaluronic acid injection

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojuan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF - China Basin Imaging Center

San Francisco, California, United States

Countries

United States

Other Identifiers

Ferring-Euflexxa

Identifier Type: -

Identifier Source: org_study_id