Gel-One Treatment in Knee Osteoarthritis

Seikagaku

Status: Completed

Conditions: Osteoarthritis Knee

Treatments: Device: PBS; Device: Gel-One

Study type: Interventional

Funder types: Industry

Identifiers

NCT01934218

Gel/1133

Details and patient eligibility

About

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Enrollment: 814 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a knee pain
• Grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion criteria

• BMI greater than 35 kg/m2
• Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
• Had a joint replacement of the target knee

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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814 participants in 2 patient groups, including a placebo group

Gel-One

Active Comparator group

Description:

3 mL, a single intra-articular injection of Gel-One

Treatment:

Device: Gel-One

Phosphate Buffered Saline (PBS)

Placebo Comparator group

Description:

3 mL, a single intra-articular injection of PBS

Treatment:

Device: PBS