Femoral Cartilage Thickness In Patients With Lower Limb Amputation

NCT ID: NCT04422717

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Amputation Osteo Arthritis Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Habip Can Küçük, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23144161 (View on PubMed)

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.

Reference Type RESULT
PMID: 25299529 (View on PubMed)

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.

Reference Type RESULT
PMID: 26163535 (View on PubMed)

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.

Reference Type RESULT
PMID: 24284270 (View on PubMed)

Other Identifiers

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IstanbulPMRTRH-HCK1

Identifier Type: -

Identifier Source: org_study_id

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