Suspended

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

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What is being tested

HYMOVIS

+ Placebo

Device
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

Over 40 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2014
See protocol details

Summary

Principal SponsorFidia Farmaceutici s.p.a.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2014

Actual date on which the first participant was enrolled.

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

Official TitleSafety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
NCT02187549
Principal SponsorFidia Farmaceutici s.p.a.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

332 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

1 inclusion criteria required to participate
Symptomatic osteoarthritis of the knee.
1 exclusion criteria prevent from participating
No disorders which could interfere with study required assessments.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
HYADD(TM) 4 Hydrogel Intra-Articular Injection

Group II

Placebo
Saline Intra-Articular Injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Suspended

Achieve Clinical Research

Birmingham, United StatesOpen Achieve Clinical Research in Google Maps
Suspended

Alabama Clinical Therapeutics

Brimingham, United States
Suspended

Elite Clinical Studies

Phoenix, United States
Suspended

Arizona Research Center

Phoenix, United States
Suspended21 Study Centers