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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04486534
Enrollment
72
Registered
2020-07-24
Start date
2020-07-26
Completion date
2021-01-15
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Amputation of Lower Extremity, Cartilage Degeneration

Keywords

Amputation, Transtibial, Prosthesis, Cartilage, Muscle

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.

Interventions

Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurementsthrough study completion, an average of one and a half monthsTalar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.

Secondary

MeasureTime frameDescription
6-minute walking testthrough study completion, an average of one and a half monthsFunctional performance will be assessed by 6-minute walking distance (in meter)
The Foot and Ankle Outcome Score (FAOS)through study completion, an average of one and a half monthsThe 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.
Short Form-36 (SF-36)through study completion, an average of one and a half monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026