NCT05246488

Brief Summary

Today, one of the frequently used scales in the evaluation of foot problems is the American Orthopedic Foot and Ankle Association Scale. AOFAS has been prepared with the American society in mind and its original version is in English. This limits the application of AOFAS to non-English speaking patients. The aim of study is to investigate the cross-cultural adaptation, reliability and validity of the Turkish version of the AOFAS Midfoot Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

February 8, 2022

Last Update Submit

September 28, 2022

Conditions

Keywords

footvalidityreliability

Outcome Measures

Primary Outcomes (2)

  • American Orthopedic Foot and Ankle Association Midfoot Scale

    The validity and reliability scale prepared by the American Orthopedic Foot-Ankle Association consists of three sub-dimensions. Evaluations in pain, function, smoothness sections and total scores range from 0 to 100 points. High scores indicate severe deformity and low scores indicate milder deformity.

    through study completion, an average of 6 months

  • Foot and Ankle Usability Measure

    FAAM is a 29-item questionnaire including 21-item activities of daily living and 8-item sports subscales. The maximum score of the 5-point Likert-type scale is 84 for activities of daily living and 32 points for the sports subscale. The total score varies between 0-100. A higher score corresponds to a higher level of function for both subscales. The validity and reliability study of the scale was carried out.

    through study completion, an average of 6 months

Secondary Outcomes (2)

  • S-12 Quality of Life Scale

    through study completion, an average of 6 months

  • Visual Analog Scale (VAS)

    through study completion, an average of 6 months

Interventions

All participants will receive two assessments, 7 days apart. After the demographic data of the patients are recorded with the form prepared by us, they will be evaluated with the AOFAS Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analogue Scale (VAS).

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

40 patients who applied to Bakirkoy Dr. Sadi Konuk Training \& Research Hospital Orthopedics and Traumatology Clinic between 15.02.2022 and 15.08.2022 and were operated due to midfoot pathologies will be included in the study.

You may qualify if:

  • Patients over the age of 18
  • Patients who were operated for Lisfranc and midfoot tarsometatarsal pathologies
  • Patients who are followed up and treated in the orthopedic service
  • Having the ability to read and write Turkish
  • Those who agreed to participate in the study

You may not qualify if:

  • patients under the age of 18
  • Patients with nerve injury and peripheral neuropathy, sensory loss, neuromuscular pathological findings, infection, acute fractures in the lower extremities, and acute rheumatic disease
  • Patients who are followed up and treated in external centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykent University

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (10)

  • Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.

    PMID: 7951968BACKGROUND
  • Celik D, Malkoc M, Martin R. Evidence for reliability, validity and responsiveness of Turkish Foot and Ankle Ability Measure (FAAM). Rheumatol Int. 2016 Oct;36(10):1469-76. doi: 10.1007/s00296-016-3485-4. Epub 2016 May 2.

    PMID: 27136921BACKGROUND
  • Celik D, Coban O. Short Form Health Survey version-2.0 Turkish (SF-36v2) is an efficient outcome parameter in musculoskeletal research. Acta Orthop Traumatol Turc. 2016 Oct;50(5):558-561. doi: 10.1016/j.aott.2016.08.013. Epub 2016 Nov 17.

    PMID: 27866914BACKGROUND
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND
  • Garcia Jimenez R, Garcia-Gomez FJ, Noriega Alvarez E, Calvo Moron C, Martin-Marcuartu JJ. Hybrid imaging in foot and ankle disorders. Rev Esp Med Nucl Imagen Mol (Engl Ed). 2018 May-Jun;37(3):191-202. doi: 10.1016/j.remn.2017.10.003. Epub 2017 Dec 6. English, Spanish.

    PMID: 29221678BACKGROUND
  • Reed MD, Van Nostran W. Assessing pain intensity with the visual analog scale: a plea for uniformity. J Clin Pharmacol. 2014 Mar;54(3):241-4. doi: 10.1002/jcph.250. Epub 2014 Jan 23. No abstract available.

    PMID: 24374753BACKGROUND
  • Analay Akbaba Y, Celik D, Ogut RT. Translation, Cross-Cultural Adaptation, Reliability, and Validity of Turkish Version of the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale. J Foot Ankle Surg. 2016 Nov-Dec;55(6):1139-1142. doi: 10.1053/j.jfas.2016.06.001. Epub 2016 Sep 7.

    PMID: 27614824BACKGROUND
  • Leigheb M, Janicka P, Andorno S, Marcuzzi A, Magnani C, Grassi F. Italian translation, cultural adaptation and validation of the "American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot scale". Acta Biomed. 2016 May 6;87(1):38-45.

    PMID: 27163894BACKGROUND
  • Vosoughi AR, Roustaei N, Mahdaviazad H. American Orthopaedic Foot and Ankle Society ankle-hindfoot scale: A cross-cultural adaptation and validation study from Iran. Foot Ankle Surg. 2018 Jun;24(3):219-223. doi: 10.1016/j.fas.2017.02.007. Epub 2017 Feb 17.

    PMID: 29409212BACKGROUND
  • Kostuj T, Krummenauer F, Schaper K, Stief F, Zettersten K, Baums MH, Meurer A, Lieske S. Analysis of agreement between the German translation of the American Foot and Ankle Society's Ankle and Hindfoot Scale (AOFAS-AHS) and the Foot Function Index in its validated German translation by Naal et al. (FFI-D). Arch Orthop Trauma Surg. 2014 Sep;134(9):1205-10. doi: 10.1007/s00402-014-2046-0. Epub 2014 Jul 11.

    PMID: 25012530BACKGROUND

MeSH Terms

Interventions

Visual Analog Scale

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • assis.prof. Altuğ Duramaz

    ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR
  • as.dr. Alican Koluman

    ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR
  • as.dr. Mehmet Utku Çiftçi

    ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR
  • assis.prof. Tansu Birinci

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral lecturer

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 18, 2022

Study Start

July 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 27, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations