Agreement Between Two Methods for Assessing Knee Joint Laxity in Patients With ACL Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Knee joint laxity (millimeters)
研究概览
简要总结
The study is a quality assurance study, aiming to determine the agreement between two different measurement instruments for assessing knee joint laxity in patients with ACL injuries.
The study aims to include 60 patients with previous ACL injury, recruited in an outpatient clinic at Aarhus University Hospital from September 2022 to March 2023. For patients who consent to participate in the study, their knee joint laxity in both the injured and the non-injured knee is assessed using both a Rolimeter and a Lachmeter. Subsequently, the collected data are examined to determined the agreement between the two measurement instruments.
详细描述
Methods:
In connection with their visit at either the orthopaedic or physiotherapy outpatient clinic, patients are invited to participate in the study. Patients consenting to participate will undergo knee joint laxity tests with both the Rolimeter and the Lachmeter, and in addition health-related and demographic data are collected.
The two tests are performed in random order for each patient, and the same physiotherapist conducts the two tests in each individual patient. The physiotherapist performing the two tests reads and notes the score on the first test, while a different physiotherapist, blinded to the score of the first test, reads and notes the score on the second test.
Agreement between the two scores are investigated using a Bland-Altman plot, with calculation of bias and upper and lower limits of agreements with 95% CIs. A priori, an acceptable difference between the two methods is set at 1 millimeter.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Patients with ACL injury awaiting potential ACL-surgery
- •Patients with previous ACL-surgery
排除标准
- •Multiligament injury
- •PCL injury
结局指标
主要结局
Knee joint laxity (millimeters)
时间窗: For surgicaly treated patients: Between 1 year and up to 5 years post-surgery. For non-surgically treated patients: Up to 12 weeks after ACL injury.
Measurement of knee joint laxity using both a Rolimeter and a Lachmeter is conducted in connection with the patients' visit at the outpatient clinic.
次要结局
未报告次要终点
研究者
Nanna Rolving
Senior researcher
Aarhus University Hospital