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Completed

NCT Number: NCT02022930

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydros

Device

Hydros-TA

Device

Triamcinolone Acetonide

Drug

Primary outcomes

  1. Change from baseline in the WOMAC A subscale score for the treatment knee.

    Time frame: 2 weeks and 26 weeks

Secondary outcomes

  1. Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Carbylan Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 30, 2013
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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