Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture
- Conditions
- Knee Ligament; Laxity
- Registration Number
- NCT04956315
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000.
- Detailed Description
The AKA was compared to the KT-2000 at 134 N in this study, the anterior displacement and difference of both knees of every subject were measured. The first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. The second was to compare the stability in 20 healthy subjects, with a single experienced examiner. Third, we recruited 200 ACL rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
- patients with ACL rupture from our institution were included. All patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery.
- Patients aged <18 or >45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side-to-side difference （SSD） within 3 months after ACL rupture Side-to-side difference （SSD）at 134 N
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking university third hospital
🇨🇳Beijing, Beijing, China
Peking university third hospital🇨🇳Beijing, Beijing, China