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

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

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 840025
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Burmingham, Alabama, United States
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 840004
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Tucson, Arizona, United States
Investigational Site Number 840023
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Covina, California, United States
Investigational Site Number 840058
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La Mesa, California, United States
Investigational Site Number 840022
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Santa Monica, California, United States
Investigational Site Number 840050
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Farmington, Connecticut, United States
Investigational Site Number 840027
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Stamford, Connecticut, United States
Investigational Site Number 840051
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Waterbury, Connecticut, United States
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Investigational Site Number 840025
🇺🇸Burmingham, Alabama, United States