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Euflexxa for the Treatment of Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Euflexxa

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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
any clinically significant abnormal laboratory value [to be defined in detail at a later point]
any intercurrent chronic disease or condition that might interfere with the completion of the study
participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Euflexxa

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Tissue Necrosis Factor-alpha (TNF-α)

The levels of TNF-α 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.

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT03459365

First Posted

January 18, 2018

Last Updated

January 14, 2022

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03459365

Brief Title

Euflexxa for the Treatment of Osteoarthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 9, 2018 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Euflexxa

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Euflexxa

Intervention Description

Aspirations performed before each injection and at six weeks.

Primary Outcome Measure Information:

Title

Changes in hyaluronate

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in Tissue Necrosis Factor-alpha (TNF-α)

Description

Time Frame

6 months

Title

Changes in Tumor necrosis factor-stimulated gene 6 (TSG-6)

Description

Time Frame

6 months

Title

VAS pain score

Description

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).

Time Frame

2 years

Title

Veterans Rand-12 (VR-12) physical composite score (PCS)

Description

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.

Time Frame

2 years

Title

Veterans Rand-12 (VR-12) mental composite score (MCS)

Description

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.

Time Frame

2 years

Title

UCLA activity score

Description

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.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion criteria: 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 any clinically significant abnormal laboratory value [to be defined in detail at a later point] any intercurrent chronic disease or condition that might interfere with the completion of the study participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos A Higuera, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

undecided

Learn more about this trial

Euflexxa for the Treatment of Osteoarthritis

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