Pedobarographic Changes After Forefoot Reconstruction

Plantar Foot Pressure Clinical Trial

— PEDfore  

Official title:

Dynamic Pedobarography With a New Insole After Forefoot Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02643485
• Other study ID #: 10111
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2015
• Last updated: January 30, 2017
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: January 2017
• Source: Technische Universität München
• Contact: Norbert Harrasser, Dr.
• Phone: 0049 89 4140 5229
• Email: norbert.harrasser[@]gmx.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No given consent

Related Conditions & MeSH terms

• Plantar Foot Pressure

Intervention

Procedure:
• Forefoot surgery
Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS-Score (American Orthopedic Foot and Ankle Society)		2 years
Secondary	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