Euflexxa for the Treatment of Osteoarthritis

NCT03459365 | Completed Results FDA Device

• 1 other identifier: 17-1668
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and degenerative synovial fluid bio-markers in patients with knee osteoarthritis

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Change in Hyaluronate Concentration

  The concentration of hyaluronate in the synovial fluid will be measured using Fluorophore-assisted carbohydrate electrophoresis. The difference between the mean concentration at baseline and 6 months is reported.

  Baseline to 6 months

Secondary Outcomes (2)

• Changes in Tumor Necrosis Factor-stimulated Gene 6 (TSG-6)

  Baseline to 6 months

• VAS Pain Score Improvement

  Baseline to 6 months

Study Arms (1)

Euflexxa

EXPERIMENTAL

Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart.

Device: Euflexxa

Interventions

Euflexxa DEVICE

Aspirations performed before each injection and at six weeks.

Euflexxa

Eligibility Criteria

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

You may qualify if:

• OA of the knee by American College of Rheumatology criteria
• Those who failed non-pharmacological measures or simple analgesics
• moderate to severe pain score of 41 to 90 mm recorded on 100-mm visual analog scale (VAS) immediately following a 50-foot walk
• bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3 OA of the target knee
• ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
• unassisted walking 50 feet on a flat surface and going up and down stairs
• willingness and ability to complete efficacy and safety questionnaires

You may not qualify if:

• Age less than 18 years
• any major injury to the target knee within the prior 12 months
• any surgery to the target knee within the prior 12 months
• surgery to the contralateral knee or other weight-bearing
• inflammatory arthropathies
• gout or pseudogout within the previous 6 months
• radiographic acute fracture, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
• osteonecrosis of either knee
• fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
• target knee joint infection or skin disorder/ infection within the previous 6 months
• symptomatic OA of the hips, spine, or ankle; known hypersensitivity to acetaminophen, IA-BioHA, or phosphate-buffered saline solution
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the study
• history of immune disorders; vascular insufficiency of lower limbs or peripheral neuropathy
• current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
• active liver or renal disease

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Carlos Higuera
• Organization: Cleveland Clinic

higuerc@ccf.org

954 659-5430

Study Officials

• Carlos A Higuera, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Quality and Patient Safety

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: March 8, 2018
• Study Start: July 9, 2018
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)