NCT00799370已完成不适用
Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- IKS score
研究概览
简要总结
The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category.
The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 40 to 65 years old
- •patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication
- •one sided indication
- •well understanding of information note by patient, non-opposition to perform the research
- •Affiliation to a national health insurance program
排除标准
- •age < 40 or > 65 years old
- •medial osteoarthritis of knee of level superior to 2
- •bilatéral indication
- •patient opposition
- •non affiliation to a national health insurance program
- •law protected patients
- •pregnancy and breast feeding
研究组 & 干预措施
1
Experimental
Early weight bearing: immediate in postoperative
干预措施: Early weight bearing (Procedure)
2
Experimental
Delayed weight bearing: 2 months after surgery
干预措施: Delayed weight bearing (Procedure)
结局指标
主要结局
IKS score
时间窗: one year follow-up
次要结局
- IKS score(6 months follow-up)
- IKDC (International Knee Documentation Committee) score(at M2, M, M6 and one year follow-up)
- Safety follow-up(during the one year follow-up)
- VAS score of pain(at D1, D5, D15, M1, M2, M3, M6 and one year follow-up)
研究者
研究点 (2)
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