Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)
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
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 3, 2011
November 1, 2011
8 months
May 5, 2010
November 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC VAS Pain over 26 weeks
26 weeks post treatment
Secondary Outcomes (1)
WOMAC VAS Stiffness and Function over 26 weeks
26 weeks post treatment
Study Arms (3)
Hydros Joint Therapy
EXPERIMENTALExperimental viscosupplement.
Hydros-TA Joint Therapy
EXPERIMENTALExperimental viscosupplement.
Synvisc-One
ACTIVE COMPARATORCommercial control.
Interventions
Single intra-articular injection.
Single intra-articular injection
Eligibility Criteria
You may qualify if:
- \- Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre Research
London, Ontario, N6A 4G5, Canada
Related Publications (1)
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.
PMID: 25887932DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
June 2, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
October 1, 2011
Last Updated
November 3, 2011
Record last verified: 2011-11