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

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00147186

Run by

Kessler Foundation

Starts

2000-01-01

Expected to finish

2005-05-01

Last updated by the study team

2007-01-15

Who can join

Age: 41 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Kessler Medical Rehabilitation Research and Education Corporation — West Orange, New Jersey, United States

Full record on ClinicalTrials.gov

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