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Foot DeformityNCT05258695

The Turkish Version of the AOFAS Hallux MTP-IP

An observational study of Foot Deformity and Hallux Deformity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate the pain, function and alignment in patients with hallux deformities. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Foot Deformity, Hallux Deformity, Assessment, Self
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2021to 11 Apr 2022
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All participants are patients who have an hallux deformity and are treated in the orthopedic service. The participants with hallux deformity are directed for assessment following a confirmation by an orthopaedist based on the physical examinations and diagnostic imaging.

Who may be able to join

  • Aged between 18 and 65 years
  • Diagnosis of Hallux deformities
  • Continuing follow-up and treatment in the orthopedic service
  • Being able to follow simple instructions
  • Being able to read and write in Turkish

Who cannot join

  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases, or psychiatric diseases
  • Having peripheral nerve injury, peripheral neuropathy, or sensory loss in the lower extremity
  • Having heterotopic ossification, myositis ossification, or post-traumatic ankylosing in the lower extremity
  • Fracture, non-healing wound, or infection in the lower extremity

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University-Cerrahpasa

    Istanbul, Bakırkoy, 34147

Other trials in Turkey (Türkiye)

About this study

Official title: American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal-interphalangeal Joint Scale (AOFAS Hallux MTP-IP)

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate the pain, function and alignment in patients with hallux deformities. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties.

Read the detailed description

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties. Approximately seventy patients with hallux deformities will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of AOFAS Hallux MTP-IP (AOFAS Hallux MTP-IP-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Manchester-Oxford Foot Questionnaire (MOXFQ) and Short Form-12 will be determined to check the validity.

Medical subject headings
Foot Deformities, Musculoskeletal Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)

    The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is composed of 9 items, distributed over 3 categories: pain (40 points), functional aspects (50 points), and alignment (10 points), for a total of 100 points.

    Measured: Day 1

Secondary outcomes (4)

  1. The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)

    The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is composed of 9 items, distributed over 3 categories: pain (40 points), functional aspects (50 points), and alignment (10 points), for a total of 100 points.

    Measured: Within a 5-to-7-day period after the first assessment (Day 1)

  2. The Manchester-Oxford Foot Questionnaire (MOXFQ)

    The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.

    Measured: Day 1

  3. Short Form-12 (SF-12)

    Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12.

    Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.

    Measured: Day 1

  4. Visual Analogue Scale (VAS)

    Pain intensity will be measured using the Visual Analogue Scale (VAS), in which the participants will be asked to indicate their perceived pain at rest, during activity, and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on a 10 cm line using a ruler.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start15 Jul 2021
  3. Primary completion15 Oct 2021
  4. Study completion11 Apr 2022

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258695
Sponsor's protocol ID
35
Status last verified
Apr 2022
First submitted
17 Feb 2022
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Foot Deformity and Hallux Deformity, run by Istanbul University - Cerrahpasa 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 4 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 8 Oct 2024. 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?

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) (time frame: Day 1). 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 NCT05258695.

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 8 Oct 2024.

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