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

Fidia Pharma

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Device: Placebo; Device: HYMOVIS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187549

EQE7-13-01

Details and patient eligibility

About

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

Enrollment: 332 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic osteoarthritis of the knee.

Exclusion criteria

• No disorders which could interfere with study required assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

332 participants in 2 patient groups, including a placebo group

HYMOVIS

Experimental group

Description:

HYADD(TM) 4 Hydrogel Intra-Articular Injection

Treatment:

Device: HYMOVIS

Placebo

Placebo Comparator group

Description:

Saline Intra-Articular Injection

Treatment:

Device: Placebo