Exercise Device in Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty; Total Knee Replacement

• Registration Number: NCT03876431
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-03-27
• Primary Completion: 2019-08-20
• Study Completion: 2020-01-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
WOMAC	Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.	Measure of symptoms and physical disability
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.
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
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").
Satisfaction levels of the patients	At sixth week	Satisfaction levels of the patients with Global Rating of Change Score
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

Trial Locations

Locations (1)

Istanbul Faculty Medicine; 🇹🇷 Istanbul, Fatih, Turkey