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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Hydros Joint Therapy
Hydros-TA Joint Therapy
Synvisc-One
Sponsored by
Carbylan Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Hydros Joint Therapy

Hydros-TA Joint Therapy

Synvisc-One

Arm Description

Experimental viscosupplement.

Experimental viscosupplement.

Commercial control.

Outcomes

Primary Outcome Measures

WOMAC VAS Pain over 26 weeks

Secondary Outcome Measures

WOMAC VAS Stiffness and Function over 26 weeks

Full Information

First Posted
May 5, 2010
Last Updated
November 2, 2011
Sponsor
Carbylan Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01134406
Brief Title
Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carbylan Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydros Joint Therapy
Arm Type
Experimental
Arm Description
Experimental viscosupplement.
Arm Title
Hydros-TA Joint Therapy
Arm Type
Experimental
Arm Description
Experimental viscosupplement.
Arm Title
Synvisc-One
Arm Type
Active Comparator
Arm Description
Commercial control.
Intervention Type
Device
Intervention Name(s)
Hydros Joint Therapy
Other Intervention Name(s)
Hydros
Intervention Description
Single intra-articular injection.
Intervention Type
Device
Intervention Name(s)
Hydros-TA Joint Therapy
Other Intervention Name(s)
Hydros-TA
Intervention Description
Single intra-articular injection
Intervention Type
Device
Intervention Name(s)
Synvisc-One
Other Intervention Name(s)
Hylan G-F 20
Intervention Description
Single intra-articular injection.
Primary Outcome Measure Information:
Title
WOMAC VAS Pain over 26 weeks
Time Frame
26 weeks post treatment
Secondary Outcome Measure Information:
Title
WOMAC VAS Stiffness and Function over 26 weeks
Time Frame
26 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
London Health Sciences Centre Research
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887932
Citation
Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.
Results Reference
derived

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

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