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临床试验/NCT01335321
NCT01335321已完成4 期

Prospective And Randomized Study Evaluating Tthe Effect Of The Association Of Triamcinolone To The Viscosupplementation Of The Knee

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
108
试验地点
1
主要终点
Results in WOMAC, Lequesne and VAS scores

研究概览

简要总结

The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

详细描述

So far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of OA. The viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. Today there are various papers on the treatment of gonarthrosis by intraarticular injection. Several methods have shown good results. There isn't, however, a consensus on the best method. The investigators know that in the treatment of osteoarthritis, with the viscosupplementation Hylan is superior in the long term, than the infiltration with cortisone. The good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. The investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. Patients in group 1 will be subjected to infiltration procedure 6ml of Hylan. Patients in Group 2 will undergo the procedure of infiltration with 6ml of Hylan and 1ml (20mg) of hexacetonide Triamcinolone. The researcher will apply the informed consent term, the pain visual analog scale (VAS), WOMAC and Lequesne questionnaires. The questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).

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
Single (Participant)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 45 and 80 years
  • Osteoarthritis Diagnosis with radiographic evidence
  • absence of previous intraarticular knee fracture
  • absence of allergy to Synvisc or Triancil

排除标准

  • Development of Pioarthritis
  • Failure to attend to the consultations

研究组 & 干预措施

Hylan GF-20 alone

Active Comparator

This arm will receive a knee infiltration with 6ml of Hylan GF-20 only

干预措施: Hylan GF-20 alone (Drug)

Triamcinolone

Experimental

This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone

干预措施: Triamcinolone (Drug)

结局指标

主要结局

Results in WOMAC, Lequesne and VAS scores

时间窗: 4 weeks

The outcome will be measured with the WOMAC and LEQUESNE scores, both about quality of life and knee function. The subjects will also use the VAS (VISUAL ANALOGIC SCALE) of pain. The results will be compared between the two groups within 1 week and 4 weeks after the viscosupplementation.

次要结局

  • Results in WOMAC, Lequesne and VAS scores after 24 weeks(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia Uchoa Rezende

MD, PhD

University of Sao Paulo General Hospital

研究点 (1)

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