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Completed

NCT Number: NCT01618708

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

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

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Investigational Site Number 124091, London, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synvisc-One (hylan G-F 20)

Device

6-mL IA injection

PLACEBO

Device

6 mL injection of phosphate buffered saline

Primary outcomes

  1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks

    Time frame: 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 outcomes

  1. Change From Baseline in WOMAC A Score Over 26 Weeks

    Time frame: 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.

  2. Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks

    Time frame: 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.

  3. Percentage of WOMAC A1 Responder Over 26 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2012
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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