Gel-One Treatment in Knee Osteoarthritis

March 21, 2023 updated by: Seikagaku Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

814

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Sheffield, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • Cerritos, California, United States
      • Costa Mesa, California, United States
      • Garden Grove, California, United States
      • North Hollywood, California, United States
      • San Diego, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Englewood, Colorado, United States
    • Connecticut
      • Cos Cob, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Florida
      • Oviedo, Florida, United States
      • Pinellas Park, Florida, United States
      • Plantation, Florida, United States
      • Sarasota, Florida, United States
      • Tamarac, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Morton Grove, Illinois, United States
    • Kansas
      • Newton, Kansas, United States
      • Wichita, Kansas, United States
    • Louisiana
      • Lake Charles, Louisiana, United States
    • Maryland
      • Wheaton, Maryland, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New Jersey
      • Trenton, New Jersey, United States
    • New York
      • Hartsdale, New York, United States
      • New York, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • State College, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Bedford, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gel-One
3 mL, a single intra-articular injection of Gel-One
Device: Gel-One
Placebo Comparator: Phosphate Buffered Saline (PBS)
3 mL, a single intra-articular injection of PBS
Device: PBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
Time Frame: 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.
Baseline up to Week26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seikagaku Corporation

Collaborators

Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gel/1133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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