Trial | NCT02022930  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    triamcinolone ...

  • Study Participants

    510
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.
Study Started
Jan 31
2014
Primary Completion
Dec 31
2015
Study Completion
Jun 30
2016
Last Update
Aug 25
2016
Estimate

Device Hydros

Device Hydros-TA

Drug Triamcinolone Acetonide

Hydros Experimental

Hydros Joint Therapy

Hydros-TA Experimental

Hydros-TA Joint Therapy

Triamcinolone acetonide Active Comparator

Triamcinolone acetonide

Criteria 

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
No Results Posted