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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01895959
First received: July 5, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Knee Osteoarthritis
Drug: Euflexxa
Device: Magnetic Resonance Imaging (MRI)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To identify imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage in knee OA after HA injection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • To quantify synovial fluid biochemical changes using high field HRMAS NMR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To quantify cartilage matrix changes using MR T1p ad T2 mapping at 3T MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Euflexxa
Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
Other Name: hyaluronic acid injection
Device: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years
  • Symptomatic knee OA as defined by the American College of Rheumatology criteria
  • Kellgren-Lawrence grade 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 12 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
  • History of knee injures that required surgical repair
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895959

Contacts
Contact: Stephanie Murphy 415-353-9446 stephanie.taylor@ucsf.edu
Contact: Melissa Lu 415-353-4216 melissa.guan@ucsf.edu

Locations
United States, California
UCSF - China Basin Imaging Center Recruiting
San Francisco, California, United States, 94107
Contact: Stephanie Taylor    415-353-9446    stephanie.taylor@ucsf.edu   
Contact: Melissa Lu    415-353-4216    melissa.guan@ucsf.edu   
Sub-Investigator: Thomas M Link, MD         
Sub-Investigator: Erik Hansen, MD         
Sub-Investigator: Michael Ries, MD         
Sub-Investigator: Anthony Luke, MD         
Sub-Investigator: Carlin Senter, MD         
Sponsors and Collaborators
University of California, San Francisco
Ferring Pharmaceuticals
Investigators
Principal Investigator: Xiaojuan Li, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01895959     History of Changes
Other Study ID Numbers: Ferring-Euflexxa
Study First Received: July 5, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
United States: UCSF - committee on Human research

Keywords provided by University of California, San Francisco:
knee osteoarthritis (OA)
hyaluronic acid injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on October 21, 2014