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Gel-One Treatment in Knee Osteoarthritis

Primary Purpose

Osteoarthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gel-One
PBS
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knee focused on measuring Knee, Osteoarthritis, Intra-articular injection

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gel-One

Phosphate Buffered Saline (PBS)

Arm Description

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

3 mL, a single intra-articular injection of PBS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2013
Last Updated
March 21, 2023
Sponsor
Seikagaku Corporation
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01934218
Brief Title
Gel-One Treatment in Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knee
Keywords
Knee, Osteoarthritis, Intra-articular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
814 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel-One
Arm Type
Active Comparator
Arm Description
3 mL, a single intra-articular injection of Gel-One
Arm Title
Phosphate Buffered Saline (PBS)
Arm Type
Placebo Comparator
Arm Description
3 mL, a single intra-articular injection of PBS
Intervention Type
Device
Intervention Name(s)
Gel-One
Intervention Type
Device
Intervention Name(s)
PBS
Primary Outcome Measure Information:
Title
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
Description
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.
Time Frame
Baseline up to Week26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Sheffield
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Cerritos
State/Province
California
Country
United States
City
Costa Mesa
State/Province
California
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
North Hollywood
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Boulder
State/Province
Colorado
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Cos Cob
State/Province
Connecticut
Country
United States
City
Trumbull
State/Province
Connecticut
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tamarac
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Morton Grove
State/Province
Illinois
Country
United States
City
Newton
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lake Charles
State/Province
Louisiana
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Trenton
State/Province
New Jersey
Country
United States
City
Hartsdale
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
State College
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Bedford
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29644875
Citation
Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12.
Results Reference
derived

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Gel-One Treatment in Knee Osteoarthritis

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