Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
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
- 否
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
Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
干预措施: Hylan G-F 20 (Drug)
Hylan + Corticosteroid
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
Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
干预措施: Triamcinolone (Drug)
Corticosteroid
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
Vinicius Schott Gameiro
Clinical Professor
Universidade Federal Fluminense
