NCT03800225终止不适用
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年1月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Knee Laxity
研究概览
简要总结
The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anterior cruciate ligament rupture
排除标准
- •Current malignant disease
- •Rheumatoid arthritis
- •Other knee ligament instability
- •Obesity BMI >30
- •Morbus Bechterew
研究组 & 干预措施
Repair
Experimental
Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
干预措施: Repair (Procedure)
Patella tendon graft
Active Comparator
The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.
干预措施: Repair (Procedure)
结局指标
主要结局
Knee Laxity
时间窗: 12 Months
KT-1000 arthrometer
次要结局
- Pain measurement(12 Months)
- Patient reported outcome scores(12 Months)
研究者
Martin Lind
Professor
Aarhus University Hospital
研究点 (2)
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