Femoral Cartilage Thickness In Patients With Lower Limb Amputation

June 15, 2020 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
      • Istanbul, Turkey, 34186
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic Evaluation of Femoral Cartilage Thickness
Time Frame: Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trinity Amputation and Prosthesis Experience Scale (TAPES)
Time Frame: Day 1
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
Day 1
Houghton Scale
Time Frame: Day 1
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.
Day 1
Short Form - 12 (SF-12)
Time Frame: Day 1
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.
Day 1
Falls Efficacy Scale
Time Frame: Day 1
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.
Day 1
Medicare Functional Classification Levels (K levels)
Time Frame: Day 1

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
Day 1
Locomotor Capabilities Index (LCI) -5
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Habip Can Küçük, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 6, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulPMRTRH-HCK1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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