Femoral Cartilage Thickness In Patients With Lower Limb Amputation

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422717
• Other study ID #: IstanbulPMRTRH-HCK1
• Status: Completed
• Start date: February 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: June 2020
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Akkaya N, Akkaya S, Özçakar 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: 10.1177/030 — View Citation

Kesikburun S, Köroglu Ö, Yasar E, Güzelküçük Ü, 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/ — View Citation

Özçakar L, Tunç H, Öken Ö, Ünlü Z, Durmus B, Baysal Ö, Altay Z, Tok F, Akkaya N, Dogu B, Çapkin E, Bardak A, Çarli AB, Bugdayci D, Toktas H, Diraçoglu D, Gündüz B, Erhan B, Kocabas H, Erden G, Günendi Z, Kesikburun S, Omaç ÖK, Taskaynatan MA, Senel K, Ugu — View Citation

Sahin Onat S, Malas FÜ, Öztürk GT, Akkaya N, Kara M, Özçakar 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: 10.1177/03093646 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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	Day 1
Secondary	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.	Day 1