NCT02676037

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

February 2, 2016

Last Update Submit

July 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • - To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform

    2 years

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Any other foot deformity
  • Previous foot surgery (which is not related to HV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Institute of Motion Analysis and Research

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 5, 2016

Study Start

January 15, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07