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

NCT01895959 | Completed Phase 4 Results FDA Device

• 1 other identifier: Ferring-Euflexxa
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
2. 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. 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

Outcome Measures

Primary Outcomes (1)

• To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection

  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.

  3 months

Secondary Outcomes (1)

• To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy

  3 months

Other Outcomes (1)

• To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI

  3 months

Study Arms (1)

Euflexxa

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.

Drug: Euflexxa; Device: Magnetic Resonance Imaging (MRI)

Interventions

Euflexxa DRUG

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

Also known as: hyaluronic acid injection

Euflexxa

Magnetic Resonance Imaging (MRI) 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).

Euflexxa

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

UCSF - China Basin Imaging Center

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Xiaojuan Li, PhD
• Organization: University of California, San Francisco

Xiaojuan.li@ucsf.edu

415-353-4909

Study Officials

• Xiaojuan Li, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 11, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-10

Locations

US (1)