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Agreement Between Clinician and Instrumented Laxity Assessment

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ClinicalTrials.gov Identifier: NCT03309098
Recruitment Status : Not yet recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Adam Rosen, University of Nebraska, Omaha

Brief Summary:

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.


Condition or disease Intervention/treatment
Ankle Sprains Ankle Injuries and Disorders Diagnostic Test: Ligmaster Arthrometer Assessment

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Agreement Between Clinician and Instrumented Laxity Assessment
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Ankle Injury
Person who injures their ankle
Diagnostic Test: Ligmaster Arthrometer Assessment
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).



Primary Outcome Measures :
  1. Assess the diagnostic accuracy of the inversion stress test, eversion stress test and anterior drawer using an arthrometer. [ Time Frame: within 48 hours post-injury ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Recreationally active, health adults.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309098


Contacts
Contact: Adam Rosen, PhD 4025542057 arosen@unomaha.edu

Sponsors and Collaborators
University of Nebraska, Omaha

Responsible Party: Adam Rosen, Assistant Professor, University of Nebraska, Omaha
ClinicalTrials.gov Identifier: NCT03309098     History of Changes
Other Study ID Numbers: 526-17-EP
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries