Euflexxa for the Treatment of Osteoarthritis

NCT ID: NCT03459365

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2021-10-31

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

Detailed Description

The FLEXX trial was the first well-controlled, randomized, double-blind, multicenter study evaluating the efficacy of Euflexxa (1% sodium hyaluronate) therapy for knee osteoarthritis. Five-hundred-and-eighty patients were randomized to receive either Euflexxa or normal saline. There were significant improvements in the Visual analogue scale score Osteoarthritis Research Society International responder index, HRQoL, and function at 26-week follow-up.1 However, the FLEXX trial did not evaluate changes in synovial fluid bio-marker levels. The present study will be a prospective pilot study of 30 knees from subjects who receive intra-articular Euflexxa. The primary objective of this study is to prospectively determine, at 6-weeks, and 6-months post treatment, the changes in levels of synovial fluid biomarkers from pre- to post-injection in patients who receive Euflexxa. In addition, we will assess patient reported pain and patient reported outcomes up to 2 years from initiation of study.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Euflexxa

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

Group Type: EXPERIMENTAL

Euflexxa

Intervention Type: DEVICE

Aspirations performed before each injection and at six weeks.

Interventions

Euflexxa

Aspirations performed before each injection and at six weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. OA of the knee by American College of Rheumatology criteria

2. Those who failed non-pharmacological measures or simple analgesics

3. moderate to severe pain score of 41 to 90 mm recorded on 100-mm visual analog scale (VAS) immediately following a 50-foot walk

4. bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3 OA of the target knee

5. ability and willingness to use only acetaminophen as the analgesic (rescue) study medication

6. unassisted walking 50 feet on a flat surface and going up and down stairs

7. willingness and ability to complete efficacy and safety questionnaires

Exclusion Criteria

1. Age less than 18 years

2. any major injury to the target knee within the prior 12 months

3. any surgery to the target knee within the prior 12 months

4. surgery to the contralateral knee or other weight-bearing

5. inflammatory arthropathies

6. gout or pseudogout within the previous 6 months

7. radiographic acute fracture, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee

8. osteonecrosis of either knee

9. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication

10. target knee joint infection or skin disorder/ infection within the previous 6 months

11. symptomatic OA of the hips, spine, or ankle; known hypersensitivity to acetaminophen, IA-BioHA, or phosphate-buffered saline solution

12. 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

13. history of immune disorders; vascular insufficiency of lower limbs or peripheral neuropathy

14. current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)

15. active liver or renal disease

16. any clinically significant abnormal laboratory value [to be defined in detail at a later point]

17. any intercurrent chronic disease or condition that might interfere with the completion of the study

18. participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Carlos Higuera-Rueda

Vice Chair for Quality and Patient Safety

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos A Higuera, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-1668

Identifier Type: -

Identifier Source: org_study_id