The Effectiveness of Hylan GF-20 on Joint Reaction Forces and Kinematic Patterns During Gait in Patients With Knee Osteoarthritis

January 12, 2007 updated by: Kessler Foundation
The use of Hylan G-F 20 as a treatment of osteoarthritis (OA) of the knee has become popular in recent years. Typical treatment of OA of the knee includes NSAIDs and physical therapy protocols to strengthen local muscle groups and decrease pain. When these conservative treatment modalities have been exhausted, the next step is arthroplasty of the knee. Hylan G-F 20 treatments provide physicians with an intermediate mode of treatment prior to surgery. Hylan G-F 20 is a cross-linked, high molecular weight derivative of hyaluronan which can be found within the synovial capsule of the knee. This form of viscosupplementation is intended to reduce the pain suffered by those with OA by increasing the fluid levels within the synovial space, providing a cushion between the bony surfaces within the knee joint. Current studies have only looked at self-reported pain relief or Outcomes Inventories. This study aims to determine the ability of Hylan G-F 20 treatment to improve the parameters of gait of individuals who suffer from OA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Typically, when an adult suffers from OA of the knee, they are presented with two choices: conservative treatments consisting of NSAID therapy and physical therapy or surgical intervention to replace the affected knee joint. There is a third avenue of treatment that has become available in recent years. This treatment modality is viscosupplementation. Viscosupplementation consists of replacing hyaluronic acid in the synovial fluid contained in the knee joint. It has been observed that the synovial fluid of OA sufferers has less hyaluronic acid (HA), and the HA that remains is of lower molecular size and concentration Replacement of the HA contained in the synovial fluid through the use of Hylan G-F 20 has been shown in clinical studies to be clinically safe, and have the ability to provide pain relief with a minimum of adverse reactions. Clinical studies concerning the use of Hylan G-F 20 have focused on safety and efficacy in regards to pain relief in those who suffer OA. To date, there have been few studies performed looking at the efficacy of Hylan G-F 20 on the kinematics and kinetics of gait. This study will provide data on the ability of Hylan G-F 20 treatment to improve the temporal-spatial parameters of gait in those who suffer OA, as well as the ability of Hylan G-F 20 to reduce joint reaction forces in the affected knee.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Medical Rehabilitation Research and Education Corporation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ambulatory, unilateral knee OA of at leas 3 months confirmed by radiography, pain requiring NSAIDS for at least 2 months

Exclusion Criteria:

  • no trauma to target knee within last 5 years, prior viscosupplementation therapy, allergy to avian products, inflammatory disease, joint sepsis,varus/valgus >12 degrees, clinically apparent tense effusion, oral corticosteroids, intra-articular injection in any joint within the last 3 months, venous or lymphatic stasis in the leg, claudication or PVD, major surgery, arthroplasty in the target joint, arthroplasty in non-target knee within the last 6 months, current malignancy or treatment within the last 5 years, except for non-melanoma skin cancer, planned surgery during the study period, diabetes requiring insulin, use of an investigational device or drug (including glucosamine and chondroitin sulfate) within 90 days before entering the study, significant psychiatric or neurological disorder, active alcohol abuse or drug abuse within the past year.

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

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Gait kinematics, kinetics, WOMAC, VAS

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sue A Sisto, Ph.D., PT, Kessler Medical Rehabilitation Research and Education Corporation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2000

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100653

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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