Exercise Device in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2020-01-06

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.

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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.

Conditions

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Total Knee Arthroplasty Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Traditional Exercise Group

Only traditional exercises will be performed in the early post-op period.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.

Easy-Flex Group

Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.

Group Type EXPERIMENTAL

Easy-Flex

Intervention Type DEVICE

The Easy-Flex device will be used to increase knee flexion and extension ROM.

Exercise

Intervention Type OTHER

After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.

Interventions

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Easy-Flex

The Easy-Flex device will be used to increase knee flexion and extension ROM.

Intervention Type DEVICE

Exercise

After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.

Intervention Type OTHER

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No