Clinical trial NCT04422717: Femoral Cartilage Thickness In Patients With Lower Limb Amputation
Official title: Ultrasonographic Evaluation of Femoral Cartilage Thickness In Patients With Lower Limb Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Osteo Arthritis Knee
Keywords: Amputate
rehabilitation
ultrasonography
osteoarthritis
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasonographic Evaluation of Femoral Cartilage Thickness
timeFrame: Day 1
Secondary outcomes:
measure: Trinity Amputation and Prosthesis Experience Scale (TAPES)
timeFrame: Day 1
measure: Houghton Scale
timeFrame: Day 1
measure: Short Form - 12 (SF-12)
timeFrame: Day 1
measure: Falls Efficacy Scale
timeFrame: Day 1
measure: Medicare Functional Classification Levels (K levels)
timeFrame: Day 1
measure: Locomotor Capabilities Index (LCI) -5
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Habip Can Küçük, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.