Magnetic Resonance Imaging Evaluation of Lateral Ankle In... | NCT03695965

Studies
Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability

NCT03695965

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 4, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Ankle Injuries

Interventions

magnetic resonance imaging.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Oct 3, 2018

First Submission Date that Met QC Criteria

Oct 3, 2018

First Posted Date

Oct 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2018

Last Update Posted Date

Oct 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		patients with history of ankle trauma or chronic lateral ankle pain	Procedure: magnetic resonance imaging.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patients with ankle or ligaments abnormalities by examination	Magnetic resonance imaging examination will be the method for diagnosis	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided