An interventional study of Euflexxa in Osteo Arthritis Knee, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and degenerative synovial fluid bio-markers in patients with knee osteoarthritis
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.
Exclusion criteria:
Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart.
Device: Euflexxa
Aspirations performed before each injection and at six weeks.
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.
Time frame: Baseline to 6 months
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 difference in mean concentration between baseline and 6 months post injection is reported.
Time frame: Baseline to 6 months
VAS Pain Score Improvement
Change in VAS (visual analogue scale) pain score compared to baseline in the study cohort. VAS is a measure of pain with 0 being best and 10 being worst pain on a 10 cm scale (100 mm).
Time frame: Baseline to 6 months
| Milestone | Euflexxa |
|---|---|
| Started | 24 |
| Completed | 10 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Protocol violation | 8 |
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.
| mg/ml | Euflexxa |
|---|---|
| Change in Hyaluronate Concentration | 0.29568 ± 1.65476 |
The levels of TSG-6 in the synovial fluid will be measured using Enzyme-linked immunosorbent assay. The difference in mean concentration between baseline and 6 months post injection is reported.
| ng/ml | Euflexxa |
|---|---|
| Changes in Tumor Necrosis Factor-stimulated Gene 6 (TSG-6) | 3450 ± 5831 |
Change in VAS (visual analogue scale) pain score compared to baseline in the study cohort. VAS is a measure of pain with 0 being best and 10 being worst pain on a 10 cm scale (100 mm).
| mm | Euflexxa |
|---|---|
| VAS Pain Score Improvement | 40 ± 13 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Euflexxa | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) |
| Event | Euflexxa |
|---|---|
| Colorectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/10 |
10 patients (11 knees). Baseline description is at the patient level (n=10)
| Age, Continuous(years) | Euflexxa |
|---|---|
| Mean | 52 ± 11 |
| Sex: Female, Male(Participants) | Euflexxa |
|---|---|
| Female | 6 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Euflexxa |
|---|
| Body mass index, continuous(kg/m^2) | Euflexxa |
|---|---|
| Mean | 30 ± 7 |
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