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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147186
Recruitment Status : Unknown
Verified June 2005 by Kessler Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : January 15, 2007
Information provided by:
Kessler Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Hylan G-F 20 Not Applicable

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 : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 2000
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Gait kinematics, kinetics, WOMAC, VAS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147186

United States, New Jersey
Kessler Medical Rehabilitation Research and Education Corporation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Principal Investigator: Sue A Sisto, Ph.D., PT Kessler Medical Rehabilitation Research and Education Corporation Identifier: NCT00147186     History of Changes
Other Study ID Numbers: 100653
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: June 2005

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Protective Agents
Physiological Effects of Drugs