Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486534
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2020-07-16
Brief Title:
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
Sponsor:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Organization:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None