NCT03695965

Brief Summary

Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. However, 20% to 40% of patients complain of chronic instability and persistent discomfort. Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 3, 2018

Last Update Submit

October 3, 2018

Conditions

Ankle Injuries

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with ankle or ligaments abnormalities by examination

    Magnetic resonance imaging examination will be the method for diagnosis

    30 minutes

Study Arms (1)

study group

patients with history of ankle trauma or chronic lateral ankle pain

Procedure: magnetic resonance imaging.

Interventions

magnetic resonance imaging.PROCEDURE

1.5 Tesla magnet system is going to be utilized for ankle imaging. A dedicated extremity surface coil (Foot/Ankle 16-Channel Coil; Siemens Medical Solution) is used to enhance spatial resolution.

Also known as: MRI.
study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with history of ankle trauma or chronic lateral ankle pain that will be evaluated using magnetic resonance imaging.

You may qualify if:

  • \- Patients with any sex, age, complaining of chronic lateral ankle pain.

You may not qualify if:

  • Tumors at ankle region.
  • Postoperative status around the ankle.
  • Rheumatoid arthritis.
  • Comminuted fracture at the ankle.
  • Congenital anomalies of the ankle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

October 4, 2018

Record last verified: 2018-10