The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Assessment of Talar Cartilage, Tibialis Antetior and Gastrocnemius Muscles in Patients With Unilateral Traumatic Transtibial Amputation: a Clinical and Sonographic-controlled Study

Conditions
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Traumatic Amputation of Lower Extremity, Cartilage Degeneration

Intervention / Treatment
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* Other: Musculoskeletal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18-65 Patients who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation Patients who have been using prostheses for at least 3 months Exclusion Criteria: Bilateral amputation Previous history of any trauma/surgical history of the lower extremities (other than amputation) Rheumatic diseases Contracture of the knee and the ankle of the intact limb

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>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 | Other: Musculoskeletal ultrasound<br>* Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.<br>|
| Control group<br>36 age and body mass index (BMI)-matched healthy controls | Other: Musculoskeletal ultrasound<br>* Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Transtibial, Prosthesis, Cartilage, Muscle