Agreement Between Clinician and Instrumented Laxity Assessment

Withdrawn

• Conditions: Ankle Sprains; Ankle Injuries and Disorders
• Interventions: Diagnostic Test: Ligmaster Arthrometer Assessment

• Registration Number: NCT03309098
• Lead Sponsor: University of Nebraska

Brief Summary

Ankle injuries are the most common acute injury to the active population. It is important to ensure best practices and techniques used in clinics for evaluation are validated and consistent. This study will compare diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries.

Detailed Description

Ankle injuries, specifically lateral ankle sprains, are the most common acute injury to the active population (Hootman, Dick, \& Agel, 2007). It is important to insure the use of best practice and ensure that the techniques being utilized in clinics for evaluation are validated and consistent within the techniques. Manual testing and instrumented testing have not yet been tested within the same cohort.

The purpose of this study is to compare the diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries. Participants will be recruited at University of Nebraska at Omahas (UNO) Injury Prevention and Care Clinic and Athletic Training Room in Sapp Fieldhouse. Participants with be members of the UNO Wellness Center or UNO athlete, aged 19-80 years old. During a standard evaluation the participant will have a clinician test manual ligamentous laxity and a blinded clinician testing laxity using an arthrometer. Participation will not alter the normal treatment or care for participants. The author hypothesizes that the diagnostic accuracy for all performed test will be good to excellent when assessed for laxity and moderate to good when assessed for pain.

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-13
• Study Start: 2017-11
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-12
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Membership to University of Nebraska at Omahas Wellness Center: a student taking on campus classes or a paying community member. Acute injury occurred within one week of evaluation.

Exclusion Criteria

• Any condition that is contraindicated for manual test (i.e. fracture).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ankle Injury	Ligmaster Arthrometer Assessment	Person who injures their ankle

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of inversion stress test, eversion stress test and anterior drawer	within 48 hours post-injury	Assess the diagnostic accuracy of the inversion stress test, eversion stress test and anterior drawer using an arthrometer.