A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

Not Applicable

Completed

Conditions: Osteoarthritis, Hip

Interventions: Device: Synvisc-One (hylan G-F 20)
Device: Placebo

Registration Number: NCT01618708

Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary: The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 357

Inclusion Criteria

The participant had symptomatic osteoarthritis (OA) in the target joint
The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year

Exclusion Criteria

The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography [CT] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure
The participant had active infection in the area of the injection site
The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications
The participant used an investigational drug, device or biologic within 12 weeks of Screening
The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synvisc-One	Synvisc-One (hylan G-F 20)	Single intraarticular (IA) injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Placebo	Placebo	Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks	From baseline to Week 26	WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in WOMAC A Score Over 26 Weeks	From Baseline to Week 26	WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks	From baseline to Week 26	PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
Percentage of WOMAC A1 Responder Over 26 Weeks	From Baseline to Week 26	WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.

Trial Locations

Locations (48): Investigational Site Number 840011
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Bradenton, Florida, United States
Investigational Site Number 840044
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Asheville, North Carolina, United States
Investigational Site Number 840046
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Columbus, Ohio, United States
Investigational Site Number 840003
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Seattle, Washington, United States
Investigational Site Number 840025
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Burmingham, Alabama, United States
Investigational Site Number 840004
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Tucson, Arizona, United States
Investigational Site Number 840023
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Covina, California, United States
Investigational Site Number 840022
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Santa Monica, California, United States
Investigational Site Number 840058
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La Mesa, California, United States
Investigational Site Number 840027
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Stamford, Connecticut, United States
Investigational Site Number 840050
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Farmington, Connecticut, United States
Investigational Site Number 840051
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Waterbury, Connecticut, United States
Investigational Site Number 840036
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Fort Lauderdale, Florida, United States
Investigational Site Number 840017
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Jupiter, Florida, United States
Investigational Site Number 840038
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New Port Richey, Florida, United States
Investigational Site Number 840047
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Sarasota, Florida, United States
Investigational Site Number 840041
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Pensacola, Florida, United States
Investigational Site Number 840049
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South Miami, Florida, United States
Investigational Site Number 840002
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Chicago, Illinois, United States
Investigational Site Number 840043
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Wichita, Kansas, United States
Investigational Site Number 840012
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Lexington, Kentucky, United States
Investigational Site Number 840005
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Meridian, Idaho, United States
Investigational Site Number 840039
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Marietta, Georgia, United States
Investigational Site Number 840033
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Traverse City, Michigan, United States
Investigational Site Number 840007
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Reno, Nevada, United States
Investigational Site Number 840037
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St. Louis, Missouri, United States
Investigational Site Number 840048
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Egg Harbor Township, New Jersey, United States
Investigational Site Number 840024
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Amherst, New York, United States
Investigational Site Number 840029
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Hartsdale, New York, United States
Investigational Site Number 840014
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Rochester, New York, United States
Investigational Site Number 840028
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Raleigh, North Carolina, United States
Investigational Site Number 840045
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Wilmington, North Carolina, United States
Investigational Site Number 840013
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Altoona, Pennsylvania, United States
Investigational Site Number 840055
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Philadelphia, Pennsylvania, United States
Investigational Site Number 840026
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Mt. Pleasant, South Carolina, United States
Investigational Site Number 840018
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Reading, Pennsylvania, United States
Investigational Site Number 840052
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Memphis, Tennessee, United States
Investigational Site Number 840054
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Austin, Texas, United States
Investigational Site Number 840040
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Bedford, Texas, United States
Investigational Site Number 840010
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Dallas, Texas, United States
Investigational Site Number 840016
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Charlottesville, Virginia, United States
Investigational Site Number 840009
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Draper, Utah, United States
Investigational Site Number 124093
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Montreal, Canada
Investigational Site Number 124092
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Sherbrooke, Canada
Investigational Site Number 840042
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Phoenix, Arizona, United States
Investigational Site Number 840056
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Phoenix, Arizona, United States
Investigational Site Number 840032
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Salt Lake City, Utah, United States
Investigational Site Number 124091
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London, Canada