跳至主要内容
临床试验/NCT01810809
NCT01810809Unknown4 期

Hip Viscosupplementation: What is the Best Dosage?

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
WOMAC

研究概览

简要总结

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

详细描述

Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Met the American College of Rheumatology criteria for hip osteoarthritis
  • No hip intraarticular injections in the last 6 months

排除标准

  • Severe reaction to the procedure

研究组 & 干预措施

Articular Lavage

Active Comparator

Patients from Group Zero will receive articular lavage with saline injection

干预措施: articular lavage with saline injection (Procedure)

Group 1

Experimental

Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

干预措施: articular lavage with saline injection (Procedure)

Group 1

Experimental

Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

干预措施: 1 ampoule of Hylan GF-20 (Drug)

Group 2

Experimental

Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20

干预措施: articular lavage with saline injection (Procedure)

Group 2

Experimental

Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20

干预措施: 2 ampoules of Hylan GF-20 (Drug)

Group 3

Experimental

Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

干预措施: articular lavage with saline injection (Procedure)

Group 3

Experimental

Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

干预措施: 3 ampoules of Hylan GF-20 (Drug)

结局指标

主要结局

WOMAC

时间窗: 6 months

Pain and function assessment with WOMAC questionaire

VAS

时间窗: 6 months

Pain assessment with Visual Analogic Scale (VAS)

Lequesne

时间窗: 6 months

Pain and function assessment with Lequesne questionaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验