The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
357
6-mL IA injection
6 mL injection of phosphate buffered saline
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.
Time frame: From baseline to Week 26
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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to Week 26
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Investigational Site Number 840025
Burmingham, Alabama, United States
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Phoenix, Arizona, United States
Investigational Site Number 840056
Phoenix, Arizona, United States
Investigational Site Number 840004
Tucson, Arizona, United States
Investigational Site Number 840023
Covina, California, United States
Investigational Site Number 840058
La Mesa, California, United States
Investigational Site Number 840022
Santa Monica, California, United States
Investigational Site Number 840050
Farmington, Connecticut, United States
Investigational Site Number 840027
Stamford, Connecticut, United States
Investigational Site Number 840051
Waterbury, Connecticut, United States
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