Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Migration in mm measured with RSA (Roentgen Stereometric Analysis):
研究概览
简要总结
In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies.
The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.
详细描述
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.
Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted 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
- Treatment
- 盲法
- None
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
- •Signed informed consent
- •Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- •Varus deformity
排除标准
- •Prednisolone treatment.
- •NSAID treatment.
- •BMI > or =
- •Previous surgery in lateral knee compartment.
- •Secondary Arthrosis following fracture(s) of the tibial condyle(s).
- •Lack of informed consent.
- •Correction >12,5 mm
- •Peroperative displaced fracture of lateral bony hinge.
研究组 & 干预措施
1
Full postoperative weightbearing
干预措施: Unlimited postoperative weightbearing (Procedure)
2
Partial weightbearing 6 weeks postoperative
干预措施: Unlimited postoperative weightbearing (Procedure)
结局指标
主要结局
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
时间窗: Postoperative, at 3 month, 1 and 2 years.
次要结局
- Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.(Postoperative, at 3 month, 1 and 2 years.)
- Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.(Postoperative, at 3 month, 1 and 2 years.)
- Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.(Postoperative, at 3 month, 1 and 2 years.)