CompletedNot Applicable

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

Turkey (Türkiye)72 participantsStarted 2020-07-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements

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

Trial details

NCT IDNCT04486534

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-15

View on ClinicalTrials.gov More Traumatic Amputation of Lower Extremity trials