Exercise Device in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty is performed in patients with advanced stages of osteoarthritis who can not respond to conservative treatment, in order to reduce pain, increase range of motion, and improve function and quality of life. Continuous passive motion device continues to be used in many clinics, although it has been shown that there is no effect in total knee arthroplasty rehabilitation. The aim of the study was to assess the clinical effects of the knee exercise device on pain, ROM and function and quality of life in total knee arthroplasty rehabilitation.

Detailed Description
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Volunteers with total knee arthroplasty according to the criteria of inclusion, who will be operated in Istanbul University Istanbul Medical Faculty Orthopedics and Traumatology Department will be included this study. Participants will be randomly allocated 2 groups: easy-flex group and traditional exercise group. Exercise group will be treated with the traditional exercise program and the Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.

Official Title
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Investigation the Effectiveness of Exercise Device in the Rehabilitation of Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty, Total Knee Replacement

Intervention / Treatment
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* Device: Easy-Flex
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with TKA surgery due to the diagnosis of knee OA Between the ages of 45-80 years Patients with no difference over 5 cm in the extremity before and after surgery Exclusion Criteria: Revision TKA, Previous unicompartmental arthroplasty or tibial osteotomy, Hemophilia, Uncontrolled hypertension Rheumatic diseases, Lower extremity fractures and tumors, Neurological diseases leading to muscle weakness in the lower limbs, Patients with emotional and cognitive problems

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Exercise Group<br>Only traditional exercises will be performed in the early post-op period. | Other: Exercise<br>* After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.<br>|
| Experimental: Easy-Flex Group<br>Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program. | Device: Easy-Flex<br>* The Easy-Flex device will be used to increase knee flexion and extension ROM.<br>Other: Exercise<br>* After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change range of motion | Range of motion of knee flexion and extension | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | The levels of pain felt rest/activity will be measured using visual analogue scale (VAS). Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain. | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 
| WOMAC | Measure of symptoms and physical disability | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 
| Satisfaction levels of the patients | Satisfaction levels of the patients with Global Rating of Change Score | At sixth week | 
| Short Form 12 (SF-12) | SF-12 is used to assess physical and mental health-related quality of life. The high scores are positively correlated with the high quality of life. | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 
| 10 meter walking test | To test comfortable or maximal walking speed | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 
| 5 sit to stand | To measure performance of lower extremity | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee prosthesis, Physiotherapy, Range of motion