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Completed

NCT Number: NCT01895959

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSF - China Basin Imaging Center

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Euflexxa

Drug

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

Other names: hyaluronic acid injection

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).

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 3 months

Other outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 11, 2013
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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