Total Knee Arthroplasty, Total Knee Replacement
Conditions
Keywords
Knee prosthesis, Physiotherapy, Range of motion
Brief summary
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
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.
Interventions
DEVICEEasy-Flex
The Easy-Flex device will be used to increase knee flexion and extension ROM.
OTHERExercise
After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change range of motion | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | Range of motion of knee flexion and extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | Measure of symptoms and physical disability |
| Satisfaction levels of the patients | At sixth week | Satisfaction levels of the patients with Global Rating of Change Score |
| NPRS (Numerical Pain Rating Scale) | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | The levels of pain intensity measured using NPRS (Numerical Pain Rating Scale). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). |
| 10 meter walking test | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | To test comfortable or maximal walking speed |
| 5 sit to stand | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | To measure performance of lower extremity |
| Short Form 12 (SF-12) | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed