Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Kne injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.
Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.
详细描述
Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.
Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.
In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medial osteoarthritis in the knee (x-ray and arthroscopy)
- •Pain in medial compartment of the knee
- •Correction angle of 5 degrees or more
排除标准
- •Former or active infection in the knee
- •Rheumatoid arthritis or other similar disease
- •Neurological disease
- •Kidney disease or metabolic disease
结局指标
主要结局
Kne injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 2 years postoperataively
The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.
次要结局
- Range of motion (ROM)(2 years postoperatively)
研究者
Tor Kjetil Nerhus
Consultant Orthopaedic surgeon
Martina Hansen's Hospital