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

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

Official Title
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A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: Synvisc-One (hylan G-F 20)
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synvisc-One<br>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. | Device: Synvisc-One (hylan G-F 20)<br>* 6-mL IA injection<br>|
| Placebo Comparator: Placebo<br>Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period. | Device: Placebo<br>* 6 mL injection of phosphate buffered saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks | 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. | From baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in WOMAC A Score Over 26 Weeks | 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. | From Baseline to Week 26 | 
| Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks | 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. | From baseline to Week 26 | 
| Percentage of WOMAC A1 Responder Over 26 Weeks | 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. | From Baseline to Week 26 |