Pedobarographic Changes After Forefoot Reconstruction | NCT02643485

Studies
Pedobarographic Changes After Forefoot Reconstruction

NCT02643485

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Feb 1, 2017Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Plantar Foot Pressure

Interventions

Forefoot surgery

Countries

Germany

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jul 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Dec 29, 2015

First Submission Date that Met QC Criteria

Dec 29, 2015

First Posted Date

Dec 31, 2015Estimated

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

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

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

Static pedobarography is routinely used for pre- and postoperative questions regarding plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence, dynamic pedobarography might give some important insights in detecting plantar foot pressure after forefoot reconstruction.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Patients undergoing forefoot reconstruction of hallux valgus or hallux rigidus	Procedure: Forefoot surgery
Control group		Healthy volunteers (Students)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Forefoot surgery	Procedure	Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AOFAS-Score (American Orthopedic Foot and Ankle Society)		2 years

Secondary Outcomes

Measure	Description	Time Frame
Plantar Peak Pressure	Measuring will be performed by insole (Fa. Meticon) capable to detect plantar pressure in 80 regions of the sole of the foot	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Forefoot surgery for hallux valgus or rigidus planned at out departement

Exclusion Criteria:

No given consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients planned for forefoot surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norbert Harrasser, Dr.	Contact	0049 89 4140 5229		norbert.harrasser@gmx.net
Rüdiger Eisenhart-Rothe, Prof.	Contact	0049 89 4140 2271		eisenhart@tum.de

Overall Officials

Name	Affiliation	Role
Rüdiger Eisenhart-Rothe, Prof.	Head of Orthopedic Dept.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar	Recruiting	Munich	Bavaria	81675	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided