Pedobarographic Changes After Forefoot Reconstruction (PEDfore)

January 30, 2017 updated by: Harrasser, Technical University of Munich

Dynamic Pedobarography With a New Insole After Forefoot Reconstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rüdiger Eisenhart-Rothe, Prof.
  • Phone Number: 0049 89 4140 2271
  • Email: eisenhart@tum.de

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Klinikum Rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients planned for forefoot surgery

Description

Inclusion Criteria:

  • Forefoot surgery for hallux valgus or rigidus planned at out departement

Exclusion Criteria:

  • No given consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients undergoing forefoot reconstruction of hallux valgus or hallux rigidus
Procedure: Forefoot surgery
Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)
Control group
Healthy volunteers (Students)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Director: Rüdiger Eisenhart-Rothe, Prof., Head of Orthopedic Dept.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (ESTIMATE)

December 31, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 10111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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