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

February 16, 2021 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06100
        • Merve Orucu Atar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of one and a half months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of one and a half months
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)
through study completion, an average of one and a half months
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.
through study completion, an average of one and a half months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 26, 2020

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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