Standard Deviation of the Distance Between the Sural Nerv... | NCT01112605

Studies
Standard Deviation of the Distance Between the Sural Nerve and Achilles Tendon by Ultrasound

NCT01112605

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Jul 19, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Israel

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

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

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

Jul 16, 2011

Last Update Posted Date

Jul 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to define the standardization of the distance between the Sural nerve & Achilles tendon, in otherwise healthy persons and athletes.

Detailed Description

The distance between the two anatomic structures is measured by US and data is analyzed to define the standardized distance in the population in order to avoid damage to the sural nerve while repairing an Achilles tendon rupture using the percutaneous methode.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
otherwise healthy persons		healthy persons, no major trauma or surgery of ankle or calves, no bone or muscle disease, age 18-60

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distance between the Sural nerve & the Achilles tendon	one time measurment of the distance between the sural nerve & the Achilles tendon, using an US device.	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
age 18-60

Exclusion Criteria:

known bone or muscle disease
major trauma to the leg or ankle in present or past
surgery of leg or ankle in the past
mental disabilities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

otherwise healthy persones, age 18-60, community sample.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer Mei-Dan, Dr.	Meir Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba			Israel