---
title: The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
nct_id: NCT04486534
overall_status: COMPLETED
sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
study_type: OBSERVATIONAL
primary_condition: Traumatic Amputation of Lower Extremity
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04486534.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04486534"
ct_last_update_post_date: 2021-02-17
last_seen_at: "2026-05-12T06:35:42.414Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04486534](https://clinicaltrials.gov/study/NCT04486534)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- **Conditions:** Traumatic Amputation of Lower Extremity, Cartilage Degeneration
- **Start Date:** 2020-07-26
- **Completion Date:** 2021-01-15
- **CT.gov Last Update:** 2021-02-17

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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
- **Control group** — 36 age and body mass index (BMI)-matched healthy controls

## Interventions

- **Musculoskeletal ultrasound** (OTHER) — Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **6-minute walking test** _(time frame: 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)_
- **Short Form-36 (SF-36)** _(time frame: through study completion, an average of one and a half months)_

## Locations (1)

- Merve Orucu Atar, Ankara, Cankaya, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.merve orucu atar|ankara|cankaya|turkey (türkiye)` — added _(2026-05-12)_

---

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