Euflexxa for the Treatment of Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

A Prospective Pilot Study to Evaluate Efficacy and Safety of Euflexxa for the Treatment of Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459365
• Other study ID #: 17-1668
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 25 subjects who will 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Euflexxa
Aspirations performed before each injection and at six weeks.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hyaluronate	The concentration of hyaluronate in the synovial fluid will be measured using Fluorophore-assisted carbohydrate electrophoresis. The mean concentration at baseline, and the change in mean concentration with the injection will be studied.	6 months
Secondary	Changes in Tissue Necrosis Factor-alpha (TNF-a)	The levels of TNF-a in the synovial fluid will be measured using Enzyme-linked immunosorbent assay. The mean concentration at baseline, and the change in mean concentration with the injection will be studied.	6 months
Secondary	Changes in Tumor necrosis factor-stimulated gene 6 (TSG-6)	The levels of TSG-6 in the synovial fluid will be measured using Enzyme-linked immunosorbent assay. The mean concentration at baseline, and the change in mean concentration with the injection will be studied.	6 months
Secondary	VAS pain score	Change in VAS (visual analogue scale) pain score compared to baseline in the study cohort. VAS is a measure of pain with 10 being worst pain on a 10cm scale (100 mm).	2 years
Secondary	Veterans Rand-12 (VR-12) physical composite score (PCS)	Change in VR-12 PCS compared to baseline in the study cohort PCS range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.	2 years
Secondary	Veterans Rand-12 (VR-12) mental composite score (MCS)	Change in VR-12 MCS compared to baseline in the study cohort. MCS range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.	2 years
Secondary	UCLA activity score	Change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.	2 years