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

Cartilage Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486534
• Other study ID #: 4
• Status: Completed
• Start date: July 26, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Cartilage Degeneration
• Traumatic Amputation of Lower Extremity

Intervention

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

Locations

Country	Name	City	State
Turkey	Merve Orucu Atar	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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