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AmputationNCT04422717

Femoral Cartilage Thickness In Patients With Lower Limb Amputation

An observational study of Amputation and Osteo Arthritis Knee, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Amputation, Osteo Arthritis Knee
How many people
75 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Feb 2019to 15 Dec 2019
How long will I take part?
1 Day
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
  • No healthy volunteers
  • Adult, Older adult

Study population: In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects accepted to enroll study.İnformed consent was taken.1 subject not acceptable with inclusion criteria was excluded.

Who may be able to join

  • Being a single lower limb amputation
  • At least one year after the amputation operation
  • Prosthesis use for the last 6 months
  • Being traumatic or vascular
  • Not having stump infection
  • Muscle strength over stump should be at least 3/5

Who cannot join

  • Doing quadriceps exercise in the last 3 months
  • Trauma, surgery, and knee injections within 6 months (PRP, hyaluronic acid), Chondroitin-glucosamine use.
  • Being any of the active synovitides, Rheumatoid arthritis, spondyloarthritis, pseudogout, coxarthrosis, neuromuscular diseases
  • Having an additional disease that will cause psychiatric adjustment problem
  • Subjects are younger than 18 years
  • Bilateral amputated

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul, 34186

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasonographic Evaluation of Femoral Cartilage Thickness In Patients With Lower Limb Amputation

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

Read the detailed description

In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical parameters at the first doctor's control. Knee radiography has been performed.

Keywords
Amputate, rehabilitation, ultrasonography, osteoarthritis
Medical subject headings
Osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasonographic Evaluation of Femoral Cartilage Thickness

    The transtibial amputee's both knees femoral cartilage are measured. The transfemoral group is measured only femoral cartilage of intact side. 10 subjects are randomised for intraobserver reliability and reevaluated one month after their first measure.

    Measured: Day 1

Secondary outcomes (6)

  1. Trinity Amputation and Prosthesis Experience Scale (TAPES)

    Trinity Amputation and Prosthesis Experience Scale(3 parts) TAPES Psychosocial maximum:75 minimum:15 points. Higher points indicate better psychosocial outcomes. TAPES activity restriction Maximum:24 minimum:0 points. Higher points indicate more activity restricted. TAPES Prosthesis Pleasant Maximum:75 Minimum:15 higher points indicate much pleasant about prothesis

    Measured: Day 1

  2. Houghton Scale

    The Houghton scale is a 4-item instrument that accesses prosthetic use in people with lower extremity amputations. It reflects a person's perception of prosthetic use. It's self-administered and easy to score. Maximum:12 points. Minimum:0 Higher scores indicate better accesses.

    Measured: Day 1

  3. Short Form - 12 (SF-12)

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Maximum:43 points minimum:12 points. Higher points indicate a higher quality of life.

    Measured: Day 1

  4. Falls Efficacy Scale

    On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling? A total score of greater than 70 indicates that the person has a fear of falling. Minimum:0 Maximum:100 points.

    Measured: Day 1

  5. Medicare Functional Classification Levels (K levels)

    Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulators.

    Level 2: Has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.

    Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

    Level 4: Typical of the prosthetic demands of the child, active adult, or athlete. Minimum: K0 Maximum: K4

    Measured: Day 1

  6. Locomotor Capabilities Index (LCI) -5

    The LCI is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced activity daily livings of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed. Maximum:56 Minimum:0 points. Higher scores indicate better locomotor capacity.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start15 Feb 2019
  3. Primary completion15 Dec 2019
  4. Study completion15 Dec 2019

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
75 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04422717
Sponsor's protocol ID
IstanbulPMRTRH-HCK1
Status last verified
Jun 2020
First submitted
6 Jun 2020
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akkaya N, Akkaya S, Ozcakar L, Demirkan F, Kiter E, Konukcu S, Ardic F. Ultrasonographic measurement of the distal femoral cartilage thickness in patients with unilateral transtibial amputation. Prosthet Orthot Int. 2013 Aug;37(4):268-74. doi: 10.1177/0309364612464233. Epub 2012 Nov 9.

    PubMed 23144161

  • Kesikburun S, Koroglu O, Yasar E, Guzelkucuk U, Yazcoglu K, Tan AK. Comparison of Intact Knee Cartilage Thickness in Patients with Traumatic Lower Extremity Amputation and Nonimpaired Individuals. Am J Phys Med Rehabil. 2015 Aug;94(8):602-8. doi: 10.1097/PHM.0000000000000216.

    PubMed 25299529

  • Sahin Onat S, Malas FU, Ozturk GT, Akkaya N, Kara M, Ozcakar L. Ultrasonographic assessment of the quadriceps muscle and femoral cartilage in transtibial amputees using different prostheses. Prosthet Orthot Int. 2016 Aug;40(4):484-9. doi: 10.1177/0309364615592701. Epub 2015 Jul 9.

    PubMed 26163535

  • Ozcakar L, Tunc H, Oken O, Unlu Z, Durmus B, Baysal O, Altay Z, Tok F, Akkaya N, Dogu B, Capkin E, Bardak A, Carli AB, Bugdayci D, Toktas H, Diracoglu D, Gunduz B, Erhan B, Kocabas H, Erden G, Gunendi Z, Kesikburun S, Omac OK, Taskaynatan MA, Senel K, Ugur M, Yalcinkaya EY, Ones K, Atan C, Akgun K, Bilgici A, Kuru O, Ozgocmen S. Femoral cartilage thickness measurements in healthy individuals: learning, practicing and publishing with TURK-MUSCULUS. J Back Musculoskelet Rehabil. 2014;27(2):117-24. doi: 10.3233/BMR-130441.

    PubMed 24284270

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation and Osteo Arthritis Knee, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites 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 6 inclusion and 6 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Ultrasonographic Evaluation of Femoral Cartilage Thickness (time frame: Day 1). 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 NCT04422717, which also lists 4 linked publications.

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 Jun 2020.

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