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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134406
• Other study ID #: COR 1.0
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: November 2, 2011
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Carbylan Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBelgium: Institutional Review BoardNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.

The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.

Exclusion Criteria:

• Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.

• Generalized symptomatic OA in lower extremity joints other than the knees.

• Active infection in either knee joint or adjacent tissues.

• Any contraindications for intra-articular injection or aspiration.

• Knee surgery or trauma within 3 months prior to enrollment.

• Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment.

• Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.

• Body Mass Index (BMI) greater than 35.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Hydros Joint Therapy
Single intra-articular injection.
• Hydros-TA Joint Therapy
Single intra-articular injection
• Synvisc-One
Single intra-articular injection.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre Research	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Carbylan Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC VAS Pain over 26 weeks		26 weeks post treatment	No
Secondary	WOMAC VAS Stiffness and Function over 26 weeks		26 weeks post treatment	No