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

NCT01134406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2011-11-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Hydros Joint Therapy

Single intra-articular injection.

DEVICE

Hydros-TA Joint Therapy

Single intra-articular injection

DEVICE

Synvisc-One

Single intra-articular injection.

Sponsors & Collaborators

  • Carbylan Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2011-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134406 on ClinicalTrials.gov