Clinical trial NCT04486534: The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Amputation of Lower Extremity
Cartilage Degeneration
Keywords: Amputation
Transtibial
Prosthesis
Cartilage
Muscle
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched healthy controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
measure: 6-minute walking test
timeFrame: through study completion, an average of one and a half months
measure: The Foot and Ankle Outcome Score (FAOS)
timeFrame: through study completion, an average of one and a half months
measure: Short Form-36 (SF-36)
timeFrame: through study completion, an average of one and a half months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Merve Orucu Atar
state: Cankaya
Study officials:
affiliation: Gaziler PMR, Training and Research Hospital, Department of PMR
name: Merve Orucu Atar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orucu Atar M, Bilgin E, Demir Y, Korkmaz N, Gurcay E. Comparison of thicknesses of talar cartilage, tibialis anterior, and gastrocnemius muscles between high-activity patients with unilateral traumatic transtibial amputation and nonamputated individuals: A clinical and sonographic study. Prosthet Orthot Int. 2022 Oct 1;46(5):459-465. doi: 10.1097/PXR.0000000000000159. Epub 2022 Jul 1.