Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Device: Placebo; Device: HYMOVIS

• Registration Number: NCT02187549
• Lead Sponsor: Fidia Farmaceutici s.p.a.

Brief Summary

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Symptomatic osteoarthritis of the knee.

Exclusion Criteria

• No disorders which could interfere with study required assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline Intra-Articular Injection
HYMOVIS	HYMOVIS	HYADD(TM) 4 Hydrogel Intra-Articular Injection

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score	26 weeks

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment	26 weeks

Trial Locations

Locations (21)

Fabio Orozco; 🇺🇸 Egg Harbor Township, New Jersey, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Suncoast Clinical Research; 🇺🇸 New Port Richey, Florida, United States

Healthcare Research Network; 🇺🇸 Hazelwood, Missouri, United States

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Chase Medical; 🇺🇸 Waterbury, Connecticut, United States

New Horizons; 🇺🇸 Cincinnati, Ohio, United States

Great Lakes Research Group; 🇺🇸 Bay City, Michigan, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Triwest Research Associates; 🇺🇸 El Cajon, California, United States

Med Center; 🇺🇸 Carmichael, California, United States

Colorado Orthopedic Consultants; 🇺🇸 Englewood, Colorado, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Alabama Clinical Therapeutics; 🇺🇸 Brimingham, Alabama, United States

Westlake Medical; 🇺🇸 Thousand Oaks, California, United States

Riverside Clinical Research; 🇺🇸 Edgewater, Florida, United States

Ormond Medical Arts; 🇺🇸 Ormond Beach, Florida, United States

PMG Research of Raleigh; 🇺🇸 Raleigh, North Carolina, United States

West Houston Clinical Research; 🇺🇸 Houston, Texas, United States

Blair Orphopedics; 🇺🇸 Altoona, Pennsylvania, United States

Columbus Clinical Research; 🇺🇸 Columbus, Ohio, United States