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

Carbylan Therapeutics

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Device: Hydros; Device: Hydros-TA; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02022930

COR1.1

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.

Enrollment: 510 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
• Symptoms in the index knee for at least 12 months.
• Fully ambulatory Subject (ability to perform a 15 meters walk test).
• Male and female Subjects 40 through 85 years of age.

Exclusion criteria

• BMI >40 kg
• Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
• Intra articular steroid therapy in last 3 months
• Intra articular viscosupplementation in last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 3 patient groups

Hydros

Experimental group

Description:

Hydros Joint Therapy

Treatment:

Device: Hydros

Hydros-TA

Experimental group

Description:

Hydros-TA Joint Therapy

Treatment:

Device: Hydros-TA

Triamcinolone acetonide

Active Comparator group

Description:

Triamcinolone acetonide

Treatment:

Drug: Triamcinolone Acetonide