SYNV-004-02: A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients with Osteoarthritis of the Hip

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00131326

Purpose

This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.

Condition	Intervention	Phase
Osteoarthritis, Hip Musculoskeletal Diseases	Device: Synvisc (hylan G-F 20)	Phase III

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details:

Primary Outcomes: Pain relief

Study start: November 2003; Study completion: April 2006

Eligibility

Ages Eligible for Study: 35 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Patients with symptomatic osteoarthritis pain of hip

Exclusion Criteria:

Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety

Location Information

Alabama
Sports Medicine, Huntsville, Alabama, 35802, United States
Alabama Clinical Therapeutics, Birmingham, Alabama, 35235, United States

Arizona
Affiliated Orthopedic Specialists, Scottsdale, Arizona, 85260, United States

Arkansas
Arkansas Orthopaedic Specialists, Little Rock, Arkansas, 72205, United States

California
Sharp Healthcare, San Diego, California, 92123, United States
Jackson Arthritis Center, Oakland, California, 94609, United States
Kerlan Jobe Orthopedic Clinic, Los Angeles, California, 90045, United States

Florida
Orthopedic Institute at Mercy Hospital, Miami, Florida, 33133, United States
Orthopedic Specialists, Clearwater, Florida, 33756, United States

Idaho
Idaho Arthritis & Osteoporosis Center, Meridian, Idaho, 83642, United States

Illinois
Illinois Bone and Joint Institute, Ltd., Morton Grove, Illinois, 60053, United States
Northwestern Orthopaedic Institute, Chicago, Illinois, 60611, United States

Iowa
Physician's Clinic of Iowa, Cedar Rapids, Iowa, 52401-2152, United States

Kansas
Kansas City Orthopedic Group, Leawood, Kansas, 66211, United States

Kentucky
Bluegrass Orthopaedics, Lexington, Kentucky, 40509, United States

Louisiana
Special Surgery Center, Shreveport, Louisiana, 71109, United States

Maryland
Johns Hopkins University, Baltimore, Maryland, 21239, United States

Michigan
Family Orthopedic Associates, Flint, Michigan, 48507, United States

New Jersey
UMDNJ-RWJ University Orthopedic Group, New Brunswick, New Jersey, 08901, United States

New York
Hospital for Special Surgery, New York, New York, 10021, United States

Ohio
Hughston Sports Medicine Foundation, Columbus, Ohio, 31909, United States

Oklahoma
Health Research Institute, Oklahoma City, Oklahoma, 73109, United States

Oregon
Orthopedic Center for Joint Replacement & Sports Medicine, Grants Pass, Oregon, 97527, United States

Pennsylvania
Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States
Allegheny Orthopedic Associates, Pittsburgh, Pennsylvania, 15212, United States
Lancaster Orthopedic Group, Lancaster, Pennsylvania, 17601, United States

South Carolina
Conway Medical Center, Conway, South Carolina, 29526, United States

Tennessee
Chattanooga Center for Sports, Chattanooga, Tennessee, 37404, United States

Texas
Private Practice, Lubbock, Texas, 79410, United States

Virginia
Lewis Gale Clinic, Inc., Salem, Virginia, 24153, United States

Washington
Arthritis Northwest, Seattle, Washington, 98166-2967, United States

More Information

Study ID Numbers: SYNV-004-02
ClinicalTrials.gov Identifier: NCT00131326
Health Authority: United States: Food and Drug Administration