Clinical Accuracy of the Lateral-Anterior Drawer Test for Diagnosing Posterior Cruciate Ligament Rupture

Phase 2

• Conditions: M23.52; M23.82

• Registration Number: DRKS00013268
• Lead Sponsor: Orthopädisches Spital Speising

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-09
• Study Completion: 2020-08-01
• Results First Posted: 2022-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Age >18 years;
Acute* or chronic* unilateral PCL rupture (confirmed by MRI scan prior to study);
Males and females;
Signed written informed consent;
First-time PCL rupture.

* In this context, acute means <3 months since the initial injury/traumatic incidence; chronic means >3 months must have passed since the injury/traumatic incidence.

Exclusion Criteria

Persons not capable of understanding spoken and/or written German;
Presence of a total knee arthroplasty;
Previous ACL and/or PCL operations at one or both knees;
Stroke or other neurological conditions that impair lower extremity function (e.g. spasticity);
Any other surgery of knee-related structures;
Any restrictions in the lower extremity joints limiting the possibility to achieve the LAD testing position of 90° flexion and neutral rotation;
Patients not able to lie supine;
Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are 1.) inter-rater reliability (Fleiss´Kappa) and 2.) intra-rater reliability (Fleiss´Kappa) of the new clinical test. <br><br>Data will be acquired using a standardized case report form (CRF). Each tester has to complete a separate CRF for each patient immediately upon completion of the testing. Completion of CRFs will be performed independently by each tester. <br>After data collection reliability will be calculated using SPSS (Version 23, IBM Corp., Armonk, N.Y., USA). Fleiss´ kappa and percent agreement values will be obtained for the three testers.<br>

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are: <br><br>1.) concurrent validity between MRI and the clinical test (lateral-anterior drawer test): sensitivity, specificity, likelihood ratios<br><br>MRIs of the knees and the clinical test will be performed in a timely manner (within one week). <br><br>2.) Determination of the correlation between the accuracy of concurrent validity and the experience of the testers with the lateral-anterior drawer test. Experience will be measured in years. <br><br>This correlation will be determined statistically immediately after the collection of all data. <br>