NCT01614288撤回不适用
A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee
University of Western Ontario, Canada1 个研究点 分布在 1 个国家开始时间: 2012年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- WOMAC
研究概览
简要总结
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.
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, Outcomes Assessor)
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
- •All patients booked for an HTO due to OA
- •Grades II to IV severity of OA by radiographic evaluation (Kellgren & Lawrence grade)
- •OA of the knee primarily involving the medial compartment
排除标准
- •Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
- •An arthroscopy of the knee within 2 years of planned surgery
- •Active joint or systemic infection,
- •Major medical illness that would preclude undergoing surgery,
- •Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
- •Major psychiatric illness, developmental handicap or inability to read and understand the English language
结局指标
主要结局
WOMAC
时间窗: Preoperatively; 3, 6, 12, 18 and 24 months
次要结局
- SF-12(Preoperatively; 3, 6, 12, 18 and 24 months)
- Gait Testing Procedures(6, 12 and 24 months post-operatively)
- The Lower Extremity Functional Scale (LEFS)(Preoperatively; 3, 6, 12, 18 and 24 months)
- Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.(Daily x 2 weeks post surgery; Weekly x 3 months)
研究者
Dianne Bryant
Associate Professor
University of Western Ontario, Canada
研究点 (1)
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