Clinical trial NCT01134406: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
knee
Lead sponsor: Carbylan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: WOMAC VAS Pain over 26 weeks
timeFrame: 26 weeks post treatment
Secondary outcomes:
measure: WOMAC VAS Stiffness and Function over 26 weeks
timeFrame: 26 weeks post treatment
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre Research
state: Ontario
Study officials:
References:
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.