NCT03876431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

February 21, 2019

Last Update Submit

May 9, 2024

Conditions

Total Knee ArthroplastyTotal Knee Replacement

Keywords

Knee prosthesisPhysiotherapyRange of motion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • NPRS (Numerical Pain Rating Scale)

    Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

  • WOMAC

    Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

  • Satisfaction levels of the patients

    At sixth week

  • Short Form 12 (SF-12)

    Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

  • 10 meter walking test

    Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

  • +1 more secondary outcomes

Study Arms (2)

Traditional Exercise Group

ACTIVE COMPARATOR

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

Other: Exercise

Easy-Flex Group

EXPERIMENTAL

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

Device: Easy-FlexOther: Exercise

Interventions

Easy-FlexDEVICE

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

Easy-Flex Group
ExerciseOTHER

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

Easy-Flex GroupTraditional Exercise Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty Medicine

Istanbul, Fatih, 34147, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Derya Çelik, Professor

    Istanbul University Faculty of Health Sciences

    STUDY DIRECTOR

  • Zeynal Yasacı

    Istanbul University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant; Principal Investigator

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 15, 2019

Study Start

March 27, 2019

Primary Completion

August 20, 2019

Study Completion

January 6, 2020

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)