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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895959
• Other study ID #: Ferring-Euflexxa
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: January 2017

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

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).

Locations

Country	Name	City	State
United States	UCSF - China Basin Imaging Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI		3 months
Primary	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	To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy		3 months