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Completed

NCT Number: NCT04486534

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

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.

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Key information

Conditions

Traumatic Amputation of Lower Extremity Cartilage Degeneration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Merve Orucu Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

musculoskeletal ultrasound

Other

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

Primary outcomes

  1. Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements

    Time frame: 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 outcomes

  1. 6-minute walking test

    Time frame: through study completion, an average of one and a half months

    Functional performance will be assessed by 6-minute walking distance (in meter)

  2. The Foot and Ankle Outcome Score (FAOS)

    Time frame: 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.

  3. Short Form-36 (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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