Agreement Between Clinician and Instrumented Laxity Assessment

NCT03309098 | Withdrawn DMC

• 1 other identifier: 0526-17-EP
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Sprains; Ankle Injuries and Disorders

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of inversion stress test, eversion stress test and anterior drawer

  Assess the diagnostic accuracy of the inversion stress test, eversion stress test and anterior drawer using an arthrometer.

  within 48 hours post-injury

Study Arms (1)

Ankle Injury

Person who injures their ankle

Diagnostic Test: Ligmaster Arthrometer Assessment

Interventions

Ligmaster Arthrometer Assessment DIAGNOSTIC_TEST

Perform an anterior drawer, inversion stress test and eversion stress test on the participant with an ankle arthrometer (LigMaster Version 1.26, Sport Tech, Inc, Charlottesville, Virginia).

Ankle Injury

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Recreationally active, health adults.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Ankle Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Rosen, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 13, 2017
• Study Start: November 28, 2017
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share