Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Asymmetry in step time between the affected and unaffected leg during down stairs walking.
研究概览
简要总结
Background:
An estimated 4000 Anterior Cruciate Ligament Injuries (ACL) occur annually in Norway (Granan et al., 2004). 1630 primary ACL reconstructions were performed in Norway in 2008 (Norwegian Arthroplasty Register, 2009). Approximately 120 of these ACL reconstructions were performed at Haraldsplass Deaconess Hospital.
Physical therapists at our hospital are responsible for postoperative outpatient controls of patients with a reconstructed anterior cruciate ligament. A clinical observation is that stair walking (especially downstairs) may be problematic up to 6 months after ACL reconstruction. One reason may be that the quadriceps muscle is unable to control the knee when the subject is walking downstairs, and that the knee is perceived to be unstable. Other contributing factors may be pain and swelling.
It is of interest to know which pre and post operative factors can predict measured and patient reported function 6 months after ACL reconstruction. Previous research shows that predictive factors for clinical outcome after ACL reconstruction are anterior knee pain (Heijne et al., 2009), preoperative electromyography, early postoperative strength (McHugh et al., 2002), preoperative quadriceps muscle strength deficits, meniscus injury and pain (Eitzen et al., 2009), obesity, smoking and serious chondrosis (Kowalchuk et al., 2009).
Purpose:
- To analyse which pre and post operative factors can predict measured and patient reported function 6 months after Anterior Cruciate Ligament reconstruction.
- To investigate if there is an asymmetry in step time between the affected and unaffected leg during down stairs walking, and if degree of asymmetry decreases during a 6 months period post operatively. Further we want to compare step time asymmetry with other established outcome measures to investigate sensitivity to change over the observation period and also compare the patient group in this study with a control group of healthy subjects to see if asymmetry in the patient group after 6 months is still higher than in healthy subjects.
详细描述
Methods:
The investigators wish to recruit 35 people scheduled for anterior cruciate ligament (ACL) reconstruction with hamstrings tendon graft.
Patients will be asked to write a training diary.
Data will be collected 1 day preoperatively, 2 days, 6 weeks, 3 months and 6 months post operatively.
Ethics:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for reconstruction of the anterior cruciate ligament with hamstrings graft at Haraldsplass Deaconess hospital.
排除标准
- •Patients with multiligament tears, meniscus suture, other problems that can influence strength testing, functional testing and gait symmetry.
结局指标
主要结局
Asymmetry in step time between the affected and unaffected leg during down stairs walking.
时间窗: 6 months postoperatively
A triaxial kinematic sensor (XSens Mtx) positioned at the level of the lower trunk will be used to identify foot strike and separate left and right steps.
Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX).
时间窗: 6 months postoperatively
Single leg hop test for distance, a 6-m timed hop test, a triple hop test for distance, a crossover hop test for distance (Noyes et al, 1991).
时间窗: 6 months postoperatively
Self reported function.
时间窗: 6 months post operatively
International Knee Documentation Committee 2000 subjective knee evaluation form.
次要结局
- Pain scores on a visual analog scale(1 day preoperatively)
- Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).(3 months postoperatively)
- The circumference around the center of the patella will be measured to assess for swelling around the knee joint.(3 months postoperatively)
- Passive range of movement compared to the healthy knee, measured with a goniometer.(3 months postoperatively)
- Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX)(1 day preoperatively)
- Asymmetry in step time between the affected and unaffected leg during down stairs walking.(3 months postoperatively)
- Self reported function(1 day preoperatively)
- Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.(3 months postoperatively)
- Pain scores on a visual analog scale.(3 months postoperatively)
- Difficulties with walking downstairs on a visual analog scale.(1 day preoperative)
- Difficulties with walking down stairs on a visual analog scale.(3 months postoperatively)
- Passive range of movement compared to the healthy knee will be measured with a goniometer.(6 weeks postoperatively)
- Knee joint laxity measured with knee laxity testing device (KT 1000).(6 weeks postoperatively)
- Knee joint laxity measured with a knee laxity testing device (KT 1000).(3 months postoperatively)