FootNCT05246488
Validation of the American Orthopedic Foot and Ankle Society Midfoot Scale
An observational study of Foot, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foot
- What is being tested?
- American Orthopedic Foot and Ankle Association Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analog Scale (VAS)
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 27 Sep 2022
- How long will I take part?
- 6 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 Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity Study of the American Orthopedic Foot and Ankle Society Midfoot Scale
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.
Read the detailed description
Foot and ankle disorders are the most common disorders affecting the musculoskeletal system and greatly affect patients' quality of life. Due to the complex anatomy and function of the foot, accurate diagnosis is an important clinical problem, making it difficult to locate the source of pain with routine clinical examination. There are many scales developed in academic studies or clinical practices to help diagnose or to evaluate foot-ankle diseases and accompanying symptoms and conditions.
The American Orthopedic Foot and Ankle Score is one of the widely used clinical outcome measures specifically designed to examine the foot and ankle. It consists of four grading systems, with each system set up to study a different anatomical area. These are the ankle-hindfoot, midfoot, hallux-metatarsophalangeal-interphalangeal, and smaller metatarsophalangeal-interphalangeal joints. The scale, which includes objective and subjective items, was developed to assess pain, function and smoothness. The original version of AOFAS is in English, which limits its application to non-English speaking patients. Some parts of AOFAS have been translated and culturally adapted into Turkish, Italian, German and Persian. The Turkish translation and cultural adaptation of AOFAS was completed only for the Ankle-Back Foot Scale out of the four rating systems. In this study, aimed to investigate the translation, cross-cultural adaptation, reliability and validity of the Turkish version of the AOFAS Midfoot Scale.
Translation and Cultural Adaptation Translation and cross-cultural adaptation of the AOFAS Midfoot Scale. It will be carried out in 5 stages, in line with the stages proposed by . In the first stage, the scale will be translated into Turkish independently by 2 Turks who have a good command of English. In the second stage, both translations will be compared in terms of conceptual errors and consistency by a bilingual translator. In the third stage, after the agreement is reached on the first Turkish translation, 2 native English speakers with a good command of Turkish will separately translate the completed Turkish translation into English. The purpose of this work will not be disclosed to both translators and they will not have access to the original English version. In the fourth stage, the translated version of the AOFAS Midfoot Scale will be compared with the original English version of the AOFAS Midfoot Scale by a committee of a methodologist, a linguist and 4 translators. The committee will be asked to evaluate the 4 translations and compare the inconsistencies and finalize them for approval.
Evaluations 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.
AOFAS Midfoot 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.
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 conducted.
S-12 Quality of Life Scale The SF-12 Quality of Life Scale is a scale to evaluate quality of life by taking 12 questions from 8 different sub-dimensions of the SF-36 Quality of Life Scale. The shorter the scale, the easier it is in terms of applicability. The scale has a different scoring method than the SF-36. In the short form SF-12, physical and mental component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. The validity and reliability study of the scale was conducted.
Visual Analog Scale, participants are asked to select the point where they feel pain on a 10-centimeter horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.
Statistical Method SPSS 25.0/Statistical Package for Social Sciences Inc; Chicago, IL, USA statistical program will be used in all statistical analyses. For all variables, mean±standard deviation and percent values will be presented within the scope of descriptive statistics. In the evaluation of test results, the level of significance will be considered as p<0.05. Measurement properties for the examined scales will be analyzed in terms of internal consistency, test-retest reliability, construct validity, floor and ceiling effects.
- Conditions
- Foot
- Being tested
- American Orthopedic Foot and Ankle Association Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analog Scale (VAS)
- Keywords
- foot, validity, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Orthopedic Foot and Ankle Association Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analog Scale (VAS)Diagnostic test
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
S-12 Quality of Life Scale
Developed by Ware et al., the SF-12 Quality of Life Scale is a scale to evaluate quality of life by taking 12 questions from 8 different sub-dimensions of the SF-36 Quality of Life Scale. The shorter the scale, the easier it is in terms of applicability. The scale has a different scoring method than the SF-36. In the short form SF-12, physical (SF12-PCS) and mental (SF12-MCS) component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. The validity and reliability study of the scale was carried out.
Measured: through study completion, an average of 6 months
Visual Analog Scale (VAS)
Participants are asked to select the point where they feel their pain on a 10-centimeter (cm) horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jul 2021
- Primary completion1 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FootStudies 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
- 57 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
- Investigators
- assis.prof. Altuğ Duramaz, Principal investigator, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITALas.dr. Alican Koluman, Principal investigator, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITALas.dr. Mehmet Utku Çiftçi, Principal investigator, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITALassis.prof. Tansu Birinci, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246488
- Sponsor's protocol ID
- UBeykent-2
- Status last verified
- Sep 2022
- First submitted
- 8 Feb 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7951968Celik 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.
PubMed 27136921Celik 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.
PubMed 27866914Beaton 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.
PubMed 11124735Garcia 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.
PubMed 29221678Reed 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.
PubMed 24374753Analay 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.
PubMed 27614824Leigheb 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.
PubMed 27163894Vosoughi 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.
PubMed 29409212Kostuj 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.
PubMed 25012530
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity Study of the American Orthopedic Foot and Ankle Society Midfoot Scale
- ClinicalTrials.gov ID
- NCT05246488
- Acronym / sponsor ID
- UBeykent-2
- Conditions
- Foot
- Keywords
- foot, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- 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.
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.
Detailed description
Foot and ankle disorders are the most common disorders affecting the musculoskeletal system and greatly affect patients' quality of life. Due to the complex anatomy and function of the foot, accurate diagnosis is an important clinical problem, making it difficult to locate the source of pain with routine clinical examination. There are many scales developed in academic studies or clinical practices to help diagnose or to evaluate foot-ankle diseases and accompanying symptoms and conditions.
The American Orthopedic Foot and Ankle Score is one of the widely used clinical outcome measures specifically designed to examine the foot and ankle. It consists of four grading systems, with each system set up to study a different anatomical area. These are the ankle-hindfoot, midfoot, hallux-metatarsophalangeal-interphalangeal, and smaller metatarsophalangeal-interphalangeal joints. The scale, which includes objective and subjective items, was developed to assess pain, function and smoothness. The original version of AOFAS is in English, which limits its application to non-English speaking patients. Some parts of AOFAS have been translated and culturally adapted into Turkish, Italian, German and Persian. The Turkish translation and cultural adaptation of AOFAS was completed only for the Ankle-Back Foot Scale out of the four rating systems. In this study, aimed to investigate the translation, cross-cultural adaptation, reliability and validity of the Turkish version of the AOFAS Midfoot Scale.
Translation and Cultural Adaptation Translation and cross-cultural adaptation of the AOFAS Midfoot Scale. It will be carried out in 5 stages, in line with the stages proposed by . In the first stage, the scale will be translated into Turkish independently by 2 Turks who have a good command of English. In the second stage, both translations will be compared in terms of conceptual errors and consistency by a bilingual translator. In the third stage, after the agreement is reached on the first Turkish translation, 2 native English speakers with a good command of Turkish will separately translate the completed Turkish translation into English. The purpose of this work will not be disclosed to both translators and they will not have access to the original English version. In the fourth stage, the translated version of the AOFAS Midfoot Scale will be compared with the original English version of the AOFAS Midfoot Scale by a committee of a methodologist, a linguist and 4 translators. The committee will be asked to evaluate the 4 translations and compare the inconsistencies and finalize them for approval.
Evaluations 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.
AOFAS Midfoot 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.
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 conducted.
S-12 Quality of Life Scale The SF-12 Quality of Life Scale is a scale to evaluate quality of life by taking 12 questions from 8 different sub-dimensions of the SF-36 Quality of Life Scale. The shorter the scale, the easier it is in terms of applicability. The scale has a different scoring method than the SF-36. In the short form SF-12, physical and mental component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. The validity and reliability study of the scale was conducted.
Visual Analog Scale, participants are asked to select the point where they feel pain on a 10-centimeter horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.
Statistical Method SPSS 25.0/Statistical Package for Social Sciences Inc; Chicago, IL, USA statistical program will be used in all statistical analyses. For all variables, mean±standard deviation and percent values will be presented within the scope of descriptive statistics. In the evaluation of test results, the level of significance will be considered as p<0.05. Measurement properties for the examined scales will be analyzed in terms of internal consistency, test-retest reliability, construct validity, floor and ceiling effects.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| American Orthopedic Foot and Ankle Association Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analog Scale (VAS)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). | Diagnostic test | – |
Primary outcome
American Orthopedic Foot and Ankle Association Midfoot Scale
Time frame: through study completion, an average of 6 months
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.
Foot and Ankle Usability Measure
Time frame: through study completion, an average of 6 months
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.
2 secondary outcomes
S-12 Quality of Life Scale
Time frame: through study completion, an average of 6 months
Visual Analog Scale (VAS)
Time frame: through study completion, an average of 6 months
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 29 Sep 2022.
- Background: PubMed 7951968Kitaoka 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.
- Background: PubMed 27136921Celik 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.
- Background: PubMed 27866914Celik 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 29221678Garcia 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.
- Background: PubMed 24374753Reed 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.
- Background: PubMed 27614824Analay 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.
- Background: PubMed 27163894Leigheb 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.
- Background: PubMed 29409212Vosoughi 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.
- Background: PubMed 25012530Kostuj 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.
- Individual participant dataSharing planned: No
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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.
assis.prof. Altuğ Duramaz principal investigator
ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
as.dr. Alican Koluman principal investigator
ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
as.dr. Mehmet Utku Çiftçi principal investigator
ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
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 Foot, run by University of Beykent at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 29 Sep 2022. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
American Orthopedic Foot and Ankle Association Midfoot Scale (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246488, which also lists 10 linked publications.
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 29 Sep 2022.