Gel-One Treatment in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis Knee
• Interventions: Device: Gel-One; Device: PBS

• Registration Number: NCT01934218
• Lead Sponsor: Seikagaku Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-06-02
• Results First Posted: 2017-07-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 814

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gel-One	Gel-One	3 mL, a single intra-articular injection of Gel-One
Phosphate Buffered Saline (PBS)	PBS	3 mL, a single intra-articular injection of PBS

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26	Baseline up to Week26	Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.