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Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2016 by University of Dundee
Sponsor:
Information provided by (Responsible Party):
University of Dundee
ClinicalTrials.gov Identifier:
NCT02676037
First received: February 2, 2016
Last updated: NA
Last verified: February 2016
History: No changes posted
  Purpose

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.


Condition Intervention
Hallux Valgus
Device: foot pressure plate form

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Cross-Sectional
Target Follow-Up Duration: 9 Months

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: February 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any other foot deformity
  • Previous foot surgery (which is not related to HV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT02676037     History of Changes
Other Study ID Numbers: 2015OS06 
Study First Received: February 2, 2016
Last Updated: February 2, 2016
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 04, 2016