Clinical trial NCT01934218: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knee
Keywords: Knee
Osteoarthritis
Intra-articular injection
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
Collaborators: name: Zimmer Biomet
First posted: 2013-09-04
Enrollment: 814
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
timeFrame: Baseline up to Week26
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Sheffield
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: San Diego
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Cos Cob
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Oviedo
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Morton Grove
country: United States
state: Illinois
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: Wheaton
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Trenton
country: United States
state: New Jersey
city: Hartsdale
country: United States
state: New York
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: State College
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
Study officials:
References:
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.