Total Knee ArthroplastyNCT03876431

Exercise Device in Total Knee Arthroplasty

A study testing Easy-Flex and Exercise in people with Total Knee Arthroplasty and Total Knee Replacement, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 80 years
Conditions the study is for: Total Knee Arthroplasty, Total Knee Replacement
What is being tested?: Easy-Flex and Exercise
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 27 Mar 2019to 6 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Faculty Medicine
Istanbul, Fatih, 34147

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Total Knee Arthroplasty, Total Knee Replacement
Being tested: Easy-Flex, Exercise
Keywords: Knee prosthesis, Physiotherapy, Range of motion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Easy-FlexDevice
The Easy-Flex device will be used to increase knee flexion and extension ROM.
ExerciseOther
After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.

Study groups in NCT03876431
Study group	Role	What they receive
Traditional Exercise Group	Active comparator	Only traditional exercises will be performed in the early post-op period. Receives: Other: Exercise
Easy-Flex Group	Experimental	Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program. Receives: Device: Easy-Flex; Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Change range of motion
Range of motion of knee flexion and extension
Measured: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

Secondary outcomes (6)

NPRS (Numerical Pain Rating Scale)
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").
Measured: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
WOMAC
Measure of symptoms and physical disability
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20196 Jan 2020

First posted15 Mar 2019
Study start27 Mar 2019
Primary completion20 Aug 2019
Study completion6 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
More trials run by Istanbul UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03876431
Sponsor's protocol ID: 12/01/2018-17939
Status last verified: May 2024
First submitted: 21 Feb 2019
Last updated: 10 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

All Total Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation the Effectiveness of Exercise Device in the Rehabilitation of Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT03876431
Acronym / sponsor ID: 12/01/2018-17939
Conditions: Total Knee Arthroplasty, Total Knee Replacement
Keywords: Knee prosthesis, Physiotherapy, Range of motion
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: 27 Mar 2019 (actual)
Primary completion: 20 Aug 2019 (actual)
Study completion: 6 Jan 2020 (actual)
First posted: 15 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Traditional Exercise Group	Active comparator	Other: ExerciseOnly traditional exercises will be performed in the early post-op period.
Easy-Flex Group	Experimental	Device: Easy-Flex, Other: ExerciseEasy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Easy-FlexThe Easy-Flex device will be used to increase knee flexion and extension ROM.	Device	Easy-Flex Group
ExerciseAfter total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.	Other	Easy-Flex Group, Traditional Exercise Group

Primary outcome

Change range of motion
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Range of motion of knee flexion and extension

6 secondary outcomes

NPRS (Numerical Pain Rating Scale)
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
WOMAC
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Satisfaction levels of the patients
Time frame: At sixth week
Short Form 12 (SF-12)
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
10 meter walking test
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
5 sit to stand
Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Individual participant dataSharing planned: No

Related trials for Total Knee Arthroplasty

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Derya Çelik, Professor study director

Istanbul University Faculty of Health Sciences

Zeynal Yasacı principal investigator

Istanbul University Faculty of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Easy-Flex and Exercise in people with Total Knee Arthroplasty and Total Knee Replacement, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change range of motion (time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03876431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.