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临床试验/NCT03090698
NCT03090698Unknown4 期

Viscosupplementation in Patients With Severe Osteoarthritis of the Knee

Universidade Federal Fluminense1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年9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
120
试验地点
1
主要终点
Lysholm M1

研究概览

简要总结

A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.

详细描述

The objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee.

There is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the Unified Health System in Brazil. For this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. Whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients.

A double-blind randomized prospective study will be held at Hospital Federal dos Servidores do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty who accept to participate and sign the informed consent form. Will be selected the last 150 knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20). The injection technique will be the same for all patients. The outcome results will be measured by a form with patient data, functional scores (Knee Society Score and Lysholm) before treatment and at one, three and six months after treatment.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Over 18 years old;
  • Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
  • Acceptance and signature of the TFCC;

排除标准

  • Infiltration of the knee for the past 6 months;
  • Allergic to any substance used in the study;
  • Prior infection in the knee.

研究组 & 干预措施

Hylan

Active Comparator

Intra-articular (knee) 6ml Hylan GF20 administration (single shot)

干预措施: Hylan G-F 20 (Drug)

Hylan + Corticosteroid

Active Comparator

Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)

干预措施: Hylan G-F 20 (Drug)

Hylan + Corticosteroid

Active Comparator

Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)

干预措施: Triamcinolone (Drug)

Corticosteroid

Active Comparator

Intra-articular (knee) 1ml Triamcinolone administration (single shot)

干预措施: Triamcinolone (Drug)

结局指标

主要结局

Lysholm M1

时间窗: One month

The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups.

KSS M1

时间窗: One month

The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups.

次要结局

  • KSS M6(Six months)
  • Lysholm M3(Three months)
  • KSS M3(Three months)
  • Lysholm M6(Six months)

研究者

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

Vinicius Schott Gameiro

Clinical Professor

Universidade Federal Fluminense

研究点 (1)

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