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A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

Primary Purpose

Osteoarthritis, Hip, Musculoskeletal Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Synvisc (hylan G-F 20)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring osteoarthritis of the hip, Musculoskeletal Diseases

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Clinical Therapeutics
  • John Higginbotham, MD Sports Medicine
  • Affiliated Orthopedic Specialists
  • Arkansas Orthopaedic Specialists
  • Cedars-Sinai Orthopedic Center
  • Jackson Arthritis Center
  • Orthopedic Medical Group
  • Orthopedic Specialists of Tamp Bay, P.A.
  • Orthopedic Institute at Mercy Hospital
  • Hughston Sports Medicine Foundation
  • Idaho Arthritis & Osteoporosis Center
  • Northwestern Orthopaedic Institute
  • Illinois Bone and Joint Institute, Ltd.
  • David S. Tearse, MD (Private Practice)
  • Kansas City Orthopedic Institute
  • Bluegrass Orthopaedics
  • Orthopedic Specialists of Louisiana
  • Maryland General Hospital
  • Family Orthopedic Associates
  • Washington University School of Medicine
  • UMDNJ-RWJ University Orthopedic Group
  • Hospital for Special Surgery
  • Health Research Institute
  • Orthopedic Center for Joint Replacement & Sports Medicine
  • Altoona Center for Clinical Research
  • Lancaster Orthopedic Group
  • Allegheny Orthopedic Associates
  • Conway Medical Center
  • Chattanooga Center for Sports
  • Gurdev Gill, MD (Private Practice)
  • Carilion Bone and Joint Center, Vinton Orthopedic Surgery
  • Arthritis Northwest

Outcomes

Primary Outcome Measures

Pain relief

Secondary Outcome Measures

Full Information

First Posted
August 17, 2005
Last Updated
July 27, 2017
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00131326
Brief Title
A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Musculoskeletal Diseases
Keywords
osteoarthritis of the hip, Musculoskeletal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Synvisc (hylan G-F 20)
Primary Outcome Measure Information:
Title
Pain relief

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
John Higginbotham, MD Sports Medicine
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Affiliated Orthopedic Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Arkansas Orthopaedic Specialists
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cedars-Sinai Orthopedic Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jackson Arthritis Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Orthopedic Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Orthopedic Specialists of Tamp Bay, P.A.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Orthopedic Institute at Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Hughston Sports Medicine Foundation
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Idaho Arthritis & Osteoporosis Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern Orthopaedic Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Illinois Bone and Joint Institute, Ltd.
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
David S. Tearse, MD (Private Practice)
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Kansas City Orthopedic Institute
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Bluegrass Orthopaedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Orthopedic Specialists of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Maryland General Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Family Orthopedic Associates
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UMDNJ-RWJ University Orthopedic Group
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Orthopedic Center for Joint Replacement & Sports Medicine
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Lancaster Orthopedic Group
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Allegheny Orthopedic Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Conway Medical Center
City
Conway
State/Province
South Carolina
ZIP/Postal Code
29526
Country
United States
Facility Name
Chattanooga Center for Sports
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Gurdev Gill, MD (Private Practice)
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Carilion Bone and Joint Center, Vinton Orthopedic Surgery
City
Vinton
State/Province
Virginia
ZIP/Postal Code
24179
Country
United States
Facility Name
Arthritis Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166-2967
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20631462
Citation
Spitzer AI, Bockow BI, Brander VA, Yates JW, MacCarter DK, Gudger GK, Haller S, Lake SL, Magilavy DB. Hylan G-F 20 improves hip osteoarthritis: a prospective, randomized study. Phys Sportsmed. 2010 Jun;38(2):35-47. doi: 10.3810/psm.2010.06.1781.
Results Reference
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A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

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