The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
- Conditions
- Traumatic Amputation of Lower ExtremityCartilage Degeneration
- Interventions
- Other: Musculoskeletal ultrasound
- Registration Number
- NCT04486534
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case group Musculoskeletal ultrasound 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 Musculoskeletal ultrasound 36 age and body mass index (BMI)-matched healthy controls
- Primary Outcome Measures
Name Time Method Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements through study completion, an average of one and a half months Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.
- Secondary Outcome Measures
Name Time Method 6-minute walking test through study completion, an average of one and a half months Functional performance will be assessed by 6-minute walking distance (in meter)
Short Form-36 (SF-36) through study completion, an average of one and a half months 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.
The Foot and Ankle Outcome Score (FAOS) through study completion, an average of one and a half months 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.
Trial Locations
- Locations (1)
Merve Orucu Atar
🇹🇷Ankara, Cankaya, Turkey