Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 4:54 PM
Study NCT ID:
NCT06635356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Replacement and Sarcopenia
Sponsor:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Organization:
Study Overview
Official Title:
Evaluation of Sarcopenia in Patients Undergoing Knee Prosthesis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The presence of sarcopenia in patients planned to undergo knee prosthesis and the effect of knee prosthesis on sarcopenia will be investigated
Detailed Description:
Volunteer patients who will undergo knee replacement surgery in orthopedic clinics located in the Istanbul region and who meet the inclusion criteria will be recruited. A total of 31 volunteers will be included in the study.
First, all patients will be asked about their gender, age, height, weight, education, smoking, lifestyle, additional diseases, and treatments they have received. Then, a brief orthopedic evaluation will be performed on the patient. TANITA BIA analysis and grip strength measurement from the dominant hand will be performed on all patients before the operation, at 1 month and 3 months after the operation. Maximal voluntary grip strength will be measured with a hand dynamometer. Measurements will be made three times. For this measurement, the subject will be asked to hold a maximal voluntary grip for five seconds. There will be a ten-second rest period between the three tests. Measurements will be made with the JAMAR Plus+ (by Sammons Preston) hand dynamometry device. Before the test measurements, the patient will be shown how to use the device as an application. The highest of the three measured values will be taken. In addition, the calf circumference will be measured. While the patient is standing, the measurement will be made with a tape measure from the thickest point of the right and left calves without squeezing the skin. The same measurement will be repeated with the patient seated. At the same time, patients will be evaluated with walking speed test, sit-to-stand test, SARC-F, FRAIL Frailty Questionnaire, Mini Nutritional Assessment, EQ-5D General Quality of Life Scale, GLIM Test, Barthel Activities of Daily Living Index, CIRS Scale before the operation, 1st month and 3rd month after the operation.
When performing the walking speed test, the patient will be asked to walk as they normally do. A 4-meter or 3-meter walking speed test will be performed and a single test will be scored. Measurements will be made twice and the fastest will be evaluated.
In the sit-to-stand test, the person will be asked to try to get up without using their arms. If they cannot complete the test or can get up using their arms, the patient will receive 0 (zero) points. If they can get up using their arms, the repeated sit-to-stand test will be performed. In the repeated sit-to-stand test, the person will be asked to sit down and get up from a chair 5 times in a row without using their arms. Scoring will be between 0-4 depending on the time spent.
First, all patients will be asked about their gender, age, height, weight, education, smoking, lifestyle, additional diseases, and treatments they have received. Then, a brief orthopedic evaluation will be performed on the patient. TANITA BIA analysis and grip strength measurement from the dominant hand will be performed on all patients before the operation, at 1 month and 3 months after the operation. Maximal voluntary grip strength will be measured with a hand dynamometer. Measurements will be made three times. For this measurement, the subject will be asked to hold a maximal voluntary grip for five seconds. There will be a ten-second rest period between the three tests. Measurements will be made with the JAMAR Plus+ (by Sammons Preston) hand dynamometry device. Before the test measurements, the patient will be shown how to use the device as an application. The highest of the three measured values will be taken. In addition, the calf circumference will be measured. While the patient is standing, the measurement will be made with a tape measure from the thickest point of the right and left calves without squeezing the skin. The same measurement will be repeated with the patient seated. At the same time, patients will be evaluated with walking speed test, sit-to-stand test, SARC-F, FRAIL Frailty Questionnaire, Mini Nutritional Assessment, EQ-5D General Quality of Life Scale, GLIM Test, Barthel Activities of Daily Living Index, CIRS Scale before the operation, 1st month and 3rd month after the operation.
When performing the walking speed test, the patient will be asked to walk as they normally do. A 4-meter or 3-meter walking speed test will be performed and a single test will be scored. Measurements will be made twice and the fastest will be evaluated.
In the sit-to-stand test, the person will be asked to try to get up without using their arms. If they cannot complete the test or can get up using their arms, the patient will receive 0 (zero) points. If they can get up using their arms, the repeated sit-to-stand test will be performed. In the repeated sit-to-stand test, the person will be asked to sit down and get up from a chair 5 times in a row without using their arms. Scoring will be between 0-4 depending on the time spent.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: