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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00131326

Collaborator

(none)

Locations

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip Musculoskeletal Diseases	Device: Synvisc (hylan G-F 20)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2003

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Pain relief []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics	Birmingham	Alabama	United States	35235
2	John Higginbotham, MD Sports Medicine	Huntsville	Alabama	United States	35802
3	Affiliated Orthopedic Specialists	Scottsdale	Arizona	United States	85260
4	Arkansas Orthopaedic Specialists	Little Rock	Arkansas	United States	72205
5	Cedars-Sinai Orthopedic Center	Los Angeles	California	United States	90048
6	Jackson Arthritis Center	Oakland	California	United States	94609
7	Orthopedic Medical Group	San Diego	California	United States	92123
8	Orthopedic Specialists of Tamp Bay, P.A.	Clearwater	Florida	United States	33756
9	Orthopedic Institute at Mercy Hospital	Miami	Florida	United States	33133
10	Hughston Sports Medicine Foundation	Columbus	Georgia	United States	31909
11	Idaho Arthritis & Osteoporosis Center	Meridian	Idaho	United States	83642
12	Northwestern Orthopaedic Institute	Chicago	Illinois	United States	60611
13	Illinois Bone and Joint Institute, Ltd.	Morton Grove	Illinois	United States	60053
14	David S. Tearse, MD (Private Practice)	Cedar Rapids	Iowa	United States	52403
15	Kansas City Orthopedic Institute	Leawood	Kansas	United States	66211
16	Bluegrass Orthopaedics	Lexington	Kentucky	United States	40509
17	Orthopedic Specialists of Louisiana	Shreveport	Louisiana	United States	71101
18	Maryland General Hospital	Baltimore	Maryland	United States	21201
19	Family Orthopedic Associates	Flint	Michigan	United States	48507
20	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
21	UMDNJ-RWJ University Orthopedic Group	New Brunswick	New Jersey	United States	08901
22	Hospital for Special Surgery	New York	New York	United States	10021
23	Health Research Institute	Oklahoma City	Oklahoma	United States	73109
24	Orthopedic Center for Joint Replacement & Sports Medicine	Grants Pass	Oregon	United States	97527
25	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
26	Lancaster Orthopedic Group	Lancaster	Pennsylvania	United States	17601
27	Allegheny Orthopedic Associates	Pittsburgh	Pennsylvania	United States	15212
28	Conway Medical Center	Conway	South Carolina	United States	29526
29	Chattanooga Center for Sports	Chattanooga	Tennessee	United States	37404
30	Gurdev Gill, MD (Private Practice)	Lubbock	Texas	United States	79410
31	Carilion Bone and Joint Center, Vinton Orthopedic Surgery	Vinton	Virginia	United States	24179
32	Arthritis Northwest	Seattle	Washington	United States	98166-2967