Euflexxa for the Treatment of Osteoarthritis

Status Completed

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03459365
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	July 9, 2018
Completion date	October 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04040985` - Legion Primary Safety and Efficacy	N/A
Active, not recruiting	`NCT04525950` - Robotized Navigation Compared to Conventional Technique in Total Knee Replacement	N/A
Recruiting	`NCT04320914` - High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis	N/A
Completed	`NCT03886142` - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis	N/A
Terminated	`NCT04072055` - MOTO Post-marketing Surveillance Study
Not yet recruiting	`NCT06385275` - The Role of Vitamin K on Knee Osteoarthritis Outcomes	Phase 1/Phase 2
Not yet recruiting	`NCT05290818` - Total Versus Robotic Assisted Unicompartmental Knee Replacement	N/A
Withdrawn	`NCT03271229` - Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee	Phase 2
Recruiting	`NCT05992038` - Use of a Putty as Gap Filler in Open-wedge Osteotomy	N/A
Recruiting	`NCT05505552` - Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:	N/A
Recruiting	`NCT06066684` - Pain Phenotyping in Knee OA: a Pilot Trial
Completed	`NCT03847324` - Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty	N/A
Recruiting	`NCT05126485` - Biofeedback Retention in Individuals With AKA	Early Phase 1
Completed	`NCT04956393` - The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study	N/A
Recruiting	`NCT04541342` - Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy	N/A
Completed	`NCT04391842` - Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis	Phase 1
Completed	`NCT03680807` - Power Production in Older Adults With Knee Osteoarthritis
Completed	`NCT03783455` - Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis	N/A
Not yet recruiting	`NCT06264362` - Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia	N/A
Completed	`NCT05089253` - Effect of Physical Therapy Modalities in Osteoarthritis	N/A