ClinicalTrials.gg
WithdrawnNCT03309098Updated Sep 3, 2024

Agreement Between Clinician and Instrumented Laxity Assessment

An observational study in Ankle Sprains and Ankle Injuries and Disorders, sponsored by University of Nebraska. Withdrawn. Open to participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by University of Nebraska · Observational

Why this study was withdrawn
IRB's initial review of this study was not completed and study was withdrawn
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
19 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Ankle Sprains
  • Ankle Injuries and Disorders
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In context

Ankle Injuries

350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.

Browse Ankle Injuries studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Recreationally active, health adults.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any condition that is for manual test (i.e. fracture).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Ankle Injury

    Person who injures their ankle

    Diagnostic Test: Ligmaster Arthrometer Assessment

Interventions

  • Diagnostic testLigmaster 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).

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What researchers measure

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.

    Time frame: within 48 hours post-injury

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Nov 2017, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Oct 13, 2017
StartActual
Nov 28, 2017
Primary completionActual
Nov 28, 2017
CompletionActual
Nov 28, 2017
Last update
Sep 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03309098
Responsible party
Sponsor
First posted
Oct 13, 2017
Start date
Nov 28, 2017
Primary completion
Nov 28, 2017
Completion
Nov 28, 2017
Last update
Sep 3, 2024

Study contacts

Adam Rosen, PhD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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