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Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower limb amputation. Although there are many studies on knee joint of intact limb of amputees in the literature, the number of studies on intact foot and ankle is extremely limited. The primary aim of the study is to compare the intact talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee patients with that of healthy individuals using ultrasound. The secondary aim is to investigate the relationship between cartilage and muscle thickness measurements with clinical parameters.
Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body mass index (BMI)-matched male controls will be participated in this cross-sectional study. Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | 36 patients between the ages of 18-65, who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation and who have been using prostheses for at least 3 months |
| |
| Control group | 36 age and body mass index (BMI)-matched healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musculoskeletal ultrasound | Other | Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements | Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound. | through study completion, an average of one and a half months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walking test | Functional performance will be assessed by 6-minute walking distance (in meter) | through study completion, an average of one and a half months |
| The Foot and Ankle Outcome Score (FAOS) |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched healthy controls
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| Name | Affiliation | Role |
|---|---|---|
| Merve Orucu Atar, MD | Gaziler PMR, Training and Research Hospital, Department of PMR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merve Orucu Atar | Ankara | Cankaya | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36215056 | Derived | Orucu Atar M, Bilgin E, Demir Y, Korkmaz N, Gurcay E. Comparison of thicknesses of talar cartilage, tibialis anterior, and gastrocnemius muscles between high-activity patients with unilateral traumatic transtibial amputation and nonamputated individuals: A clinical and sonographic study. Prosthet Orthot Int. 2022 Oct 1;46(5):459-465. doi: 10.1097/PXR.0000000000000159. Epub 2022 Jul 1. |
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The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The FAOS consists of 42 questions, divided into five different patient-relevant subscales: pain (nine questions); symptoms such as stiffness, swelling and range of motion (seven questions); activities of daily living (17 questions); ability to perform sports and recreational activities (five questions); and foot/ankle-related quality of life (four questions). Answers are given on a five-point Likert scale. Total and subscores are calculated by summing the scores of the individual items. The total score is recoded into a 0-100 scale, with 100 representing no symptoms or limitations.
| through study completion, an average of one and a half months |
| Short Form-36 (SF-36) | The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). This comprises 36 questions related to eight different subscales, physical functioning, bodily pain, role limitation, due to physical health problems, general health perceptions, vitality, energy and fatigue, role limitations due to emotional problems, social functioning and general mental health, which covers psychological distress and wellbeing. Each of eight subscales is scored between 0 and 100, with higher scores indicating a better quality of life. | through study completion, an average of one and a half months |