Gel-One Treatment in Knee Osteoarthritis

Osteoarthritis Knee Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934218
• Other study ID #: Gel/1133
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2023
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Device:
• Gel-One

• PBS

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seikagaku Corporation	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26	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.	Baseline up to Week26