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OpenTrials
Completed

NCT Number: NCT01934218

Gel-One Treatment in Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gel-One

Device

PBS

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Collaborators

  • Zimmer Biomet

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2013
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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