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

NCT04486534 | Completed

• 1 other identifier: 4
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Amputation of Lower Extremity; Cartilage Degeneration

Keywords

Amputation; Transtibial; Prosthesis; Cartilage; Muscle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 6-minute walking test

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

• The Foot and Ankle Outcome Score (FAOS)

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

• Short Form-36 (SF-36)

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

Study Arms (2)

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

Control group

36 age and body mass index (BMI)-matched healthy controls

Other: Musculoskeletal ultrasound

Interventions

Musculoskeletal ultrasound OTHER

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

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Merve Orucu Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36215056 DERIVED

Study Officials

• Merve Orucu Atar, MD

  Gaziler PMR, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 24, 2020
• Study Start: July 26, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)