Pes PlanusNCT00507910
The Development of Flat Foot After Ankle Fractures
An observational study of Pes Planus, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pes Planus
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients will be considered eligible if:
- They have sustained Weber type B or C ankle fractures and needed open reduction
- They are 18 years of age or older
- They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop
Who cannot join
- Patients will be excluded if they already have flat foot in their non-fractured foot.
- Patients with bilateral ankle fractures
- Patients who are not competent to sign a consent form
- A second fracture to the ankle
- Pathological fractures
- Patients with underlying cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pes Planus After Weber B and C Ankle Fractures
In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.
Read the detailed description
Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.
- Conditions
- Pes Planus
- Keywords
- ankle fracture, pes planus
- Medical subject headings
- Flatfoot, Ankle Fractures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Alan Giachino, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507910
- Sponsor's protocol ID
- OHREB2006542
- Status last verified
- Jul 2011
- First submitted
- 25 Jul 2007
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pes Planus After Weber B and C Ankle Fractures
- ClinicalTrials.gov ID
- NCT00507910
- Acronym / sponsor ID
- OHREB2006542
- Conditions
- Pes Planus
- Keywords
- ankle fracture, pes planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jul 2007 (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.
In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.
Detailed description
Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- They have sustained Weber type B or C ankle fractures and needed open reduction
- They are 18 years of age or older
- They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop
Key exclusion criteria (6 listed)
- Patients will be excluded if they already have flat foot in their non-fractured foot.
- Patients with bilateral ankle fractures
- Patients who are not competent to sign a consent form
- A second fracture to the ankle
- Pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Alan Giachino principal investigator
OHRI
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 Pes Planus, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Jul 2011. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 21 Jul 2011.