Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02022930

Enrollment

510

Registered

2013-12-30

Start date

2014-01-31

Completion date

2016-06-30

Last updated

2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee

Brief summary

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.

Interventions

DEVICEHydros

DEVICEHydros-TA

DRUGTriamcinolone Acetonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA. * Symptoms in the index knee for at least 12 months. * Fully ambulatory Subject (ability to perform a 15 meters walk test). * Male and female Subjects 40 through 85 years of age.

Exclusion criteria

* BMI \>40 kg * Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease. * Intra articular steroid therapy in last 3 months * Intra articular viscosupplementation in last 6 months

Design outcomes

Primary

Measure	Time frame
Change from baseline in the WOMAC A subscale score for the treatment knee.	2 weeks and 26 weeks

Secondary

Measure	Time frame
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee	26 weeks

Countries

Australia, Canada, Netherlands Antilles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026