Traumatic Amputation of Lower ExtremityNCT04486534
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
An observational study of Traumatic Amputation of Lower Extremity and Cartilage Degeneration, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Amputation of Lower Extremity, Cartilage Degeneration
- What is being tested?
- Musculoskeletal ultrasound
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Musculoskeletal ultrasound
- Keywords
- Amputation, Transtibial, Prosthesis, Cartilage, Muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal ultrasoundOther
Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Musculoskeletal ultrasound | |
| Control group | 36 age and body mass index (BMI)-matched healthy controls Receives: Other: Musculoskeletal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.
Measured: through study completion, an average of one and a half months
Secondary outcomes (3)
6-minute walking test
Functional performance will be assessed by 6-minute walking distance (in meter)
Measured: through study completion, an average of one and a half months
The Foot and Ankle Outcome Score (FAOS)
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 FAOS consists of 42 questions, divided into five different patient-relevant subscales: pain (nine questions); symptoms such as stiffness, swelling and range of motion (seven questions); activities of daily living (17 questions); ability to perform sports and recreational activities (five questions); and foot/ankle-related quality of life (four questions). Answers are given on a five-point Likert scale. Total and subscores are calculated by summing the scores of the individual items. The total score is recoded into a 0-100 scale, with 100 representing no symptoms or limitations.
Measured: through study completion, an average of one and a half months
Short Form-36 (SF-36)
The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). This comprises 36 questions related to eight different subscales, physical functioning, bodily pain, role limitation, due to physical health problems, general health perceptions, vitality, energy and fatigue, role limitations due to emotional problems, social functioning and general mental health, which covers psychological distress and wellbeing. Each of eight subscales is scored between 0 and 100, with higher scores indicating a better quality of life.
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start26 Jul 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Amputation of Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Merve Orucu Atar, MD, Principal investigator, Gaziler PMR, Training and Research Hospital, Department of PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486534
- Sponsor's protocol ID
- 4
- Status last verified
- Feb 2021
- First submitted
- 16 Jul 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36215056
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04486534
- Acronym / sponsor ID
- 4
- Keywords
- Amputation, Transtibial, Prosthesis, Cartilage, Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Musculoskeletal ultrasound36 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 | – | Other: Musculoskeletal ultrasound36 age and body mass index (BMI)-matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched healthy controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal ultrasoundSubjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound. | Other | Case group, Control group |
Primary outcome
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.
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 36215056Orucu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Orucu Atar, MD principal investigator
Gaziler PMR, Training and Research Hospital, Department of PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Amputation of Lower Extremity and Cartilage Degeneration, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements (time frame: through study completion, an average of one and a half months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.