Plantar Foot PressurePEDforeNCT02643485
Pedobarographic Changes After Forefoot Reconstruction
An observational study of Plantar Foot Pressure, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Foot Pressure
- What is being tested?
- Forefoot surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients planned for forefoot surgery
Who may be able to join
- Forefoot surgery for hallux valgus or rigidus planned at out departement
Who cannot join
- No given consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, Bavaria, 81675
Norbert Harrasser, DR., 00498941405229, norbert.harrasser@gmx.net
Ingo Banke, Dr., 00498941405284, ingo@banke.eu
About this study
Official title: 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.
- Conditions
- Plantar Foot Pressure
- Being tested
- Forefoot surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forefoot surgeryProcedure or surgery
Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing forefoot reconstruction of hallux valgus or hallux rigidus Receives: Procedure: Forefoot surgery | |
| Control group | Healthy volunteers (Students) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS-Score (American Orthopedic Foot and Ankle Society)
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Foot PressureStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrasser, Technical University of Munich
- Investigators
- Rüdiger Eisenhart-Rothe, Prof., Study director, Head of Orthopedic Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643485
- Sponsor's protocol ID
- 10111
- Acronym
- PEDfore
- Status last verified
- Jan 2017
- First submitted
- 29 Dec 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Pedobarography With a New Insole After Forefoot Reconstruction
- ClinicalTrials.gov ID
- NCT02643485
- Acronym / sponsor ID
- PEDfore / 10111
- Conditions
- Plantar Foot Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Forefoot surgeryPatients undergoing forefoot reconstruction of hallux valgus or hallux rigidus |
| Control group | – | –Healthy volunteers (Students) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for forefoot surgery
Key inclusion criteria (1 listed)
- Forefoot surgery for hallux valgus or rigidus planned at out departement
Key exclusion criteria (1 listed)
- No given consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forefoot surgeryForefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis) | Procedure or surgery | Study group |
Primary outcome
AOFAS-Score (American Orthopedic Foot and Ankle Society)
Time frame: 2 years
1 secondary outcome
Plantar Peak Pressure
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rüdiger Eisenhart-Rothe, Prof. study director
Head of Orthopedic Dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Foot Pressure, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norbert Harrasser, Dr. (0049 89 4140 5229, norbert.harrasser@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS-Score (American Orthopedic Foot and Ankle Society) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.