NCT03049423

Brief Summary

To compare the results of multi-position MRI scans for ankle ligaments and tendons to clarify how to obtain imaging data of different ankle ligaments and define severity of injuries to calculate the rate of correct diagnosis, thereby developing a reasonable surgical treatment in clinical practice.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

February 8, 2017

Last Update Submit

February 8, 2017

Conditions

Ankle Injuries

Outcome Measures

Primary Outcomes (1)

  • The sensitivity of MRI scan for ligament and tendon injury of the ankle

    The sensitivity (true positive rate) is defined as the percentage of actual patients who are correctly diagnosed with a disease. A higher sensitivity indicates a higher rate of correct diagnosis.

    during the MRI scan

Secondary Outcomes (1)

  • The specificity of MRI scan for ligament and tendon injury of the anklethe ankle

    during the MRI scan

Study Arms (2)

the trial group

30 patients with ankle ligament and tendon injury were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the trial group. Each participant was required to undergo MRI scans in normal position and during complete plantar flexion and complete dorsiflexion.

Device: MRI scans

the control group

30 patients with normal ankle joint were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the control group. Each participant was required to undergo MRI scans and general physical examination in normal position and during complete plantar flexion and complete dorsiflexion.

Diagnostic Test: MRI scans and general physical examination

Interventions

MRI scansDEVICE

30 patients with ankle ligament and tendon injury were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the trial group. Each participant was required to undergo MRI scans in normal position and during complete plantar flexion and complete dorsiflexion.

the trial group
MRI scans and general physical examinationDIAGNOSTIC_TEST

30 patients with normal ankle joint were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the control group. Each participant was required to undergo MRI scans and general physical examination in normal position and during complete plantar flexion and complete dorsiflexion.

the control group

Eligibility Criteria

Age34 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Six participants from the First Affiliated Hospital of Hebei Medical University were recruitment through newspapers, public communication, hospital and public institution websites. The participants gave written informed consent prior to participation in the trial.

You may qualify if:

  • Meet the diagnostic criteria for ankle ligament and tendon injury
  • Age 34-78 years
  • Both genders
  • Sign the informed consent prior to the trial

You may not qualify if:

  • Heart, liver, kidney and other important organ diseases
  • Ankle open fracture
  • Old fracture of the ankle joint
  • An open tendon or ligament rupture of the ankle
  • Neuropsychiatric disorders (epilepsy, depression or panic disorder)
  • Pregnant or lactating women
  • Participate in other clinical trials over the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Interventions

Magnetic Resonance ImagingPhysical Examination

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Guobin Liu, Master

    The First Affiliated Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

May 1, 2015

Primary Completion

August 1, 2016

Study Completion

May 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02