Hallux ValgusNCT02676037
Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images
An observational study of Hallux Valgus, run by University of Dundee.
Trial summary
Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- foot pressure plate form
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 1 Jun 2018
- How long will I take part?
- 9 Months
- 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: Participants will come from an existing list of patients referred to the Foot Pressure Analysis Clinic and will include any patients who are diagnosed with HV. They will be recruited with the knowledge of the consultant orthopedic surgeons who are the direct care providers for these patients. The surgeons will write to eligible participants and include a Patient Information sheet about the project (which does not require to record data beyond what is normally performed as part of the Foot Pressure Analysis Clinic) If the participant is interested in taking part he/she will contact the department.
Who may be able to join
- Patients who are diagnosed with hallux valgus.
- Patients who are diagnosed with hallux valgus and scheduled for surgery ( to be seen pre and post-surgery)
- Patient who are diagnosed with hallux valgus and had surgery
Who cannot join
- Any other foot deformity
- Previous foot surgery (which is not related to HV
About this study
Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. The main subjects will be recruited from orthopaedic outpatient clinics.
The recruited subjects will undergo the non-invasive and radiation free study by walking on a pressure platform. Then their pressure data will be correlated with their radiological study which has already been done in the clinic. The aimed outcome of the study is use the foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.
- Conditions
- Hallux Valgus
- Being tested
- foot pressure plate form
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot pressure plate formDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
- To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform
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 posted5 Feb 2016 (estimated)
- Study start15 Jan 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Abboud, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676037
- Sponsor's protocol ID
- 2015OS06
- Status last verified
- Jul 2018
- First submitted
- 2 Feb 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images
- ClinicalTrials.gov ID
- NCT02676037
- Acronym / sponsor ID
- 2015OS06
- Conditions
- Hallux Valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Feb 2016 (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.
Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. The main subjects will be recruited from orthopaedic outpatient clinics.
The recruited subjects will undergo the non-invasive and radiation free study by walking on a pressure platform. Then their pressure data will be correlated with their radiological study which has already been done in the clinic. The aimed outcome of the study is use the foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will come from an existing list of patients referred to the Foot Pressure Analysis Clinic and will include any patients who are diagnosed with HV. They will be recruited with the knowledge of the consultant orthopedic surgeons who are the direct care providers for these patients. The surgeons will write to eligible participants and include a Patient Information sheet about the project (which does not require to record data beyond what is normally performed as part of the Foot Pressure Analysis Clinic) If the participant is interested in taking part he/she will contact the department.
Key inclusion criteria (3 listed)
- Patients who are diagnosed with hallux valgus.
- Patients who are diagnosed with hallux valgus and scheduled for surgery ( to be seen pre and post-surgery)
- Patient who are diagnosed with hallux valgus and had surgery
Key exclusion criteria (2 listed)
- Any other foot deformity
- Previous foot surgery (which is not related to HV
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 |
|---|---|---|
| foot pressure plate form | Device | – |
Primary outcome
- To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform
Time frame: 2 years
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 1 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by University of Dundee.
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 3 inclusion and 2 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
- To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform (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 Aug 2018.