Knee ArthritisNCT05420194
Assessment of Postural Stability in Patients With Total Knee Arthroplasty
An observational study of Knee Arthritis and Arthroplasty Complications, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Postural balance can be described as the integration of the information obtained from visual, vestibular and somatosensory systems. Postural stability is achieved by sensory information about the static or dynamic position of the body resulting in an appropriate motor response. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Arthritis, Arthroplasty Complications, Obesity
- What is being tested?
- Postural stability measurement and Timed Up and Go test
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Sep 2022to 30 Jun 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had undergone total knee arthroplasty
Who may be able to join
- Follow-up period is between 1-5 years,
- Volunteer to participate in the study,
Who cannot join
- Having undergone revision surgery on the same or opposite knee after total knee arthroplasty,
- Presence of vertigo or another neurological disease,
- Patients who have undergone total hip replacement.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acıbadem University
Istanbul
Marmara University
Istanbul
About this study
Postural balance can be described as the integration of the information obtained from visual, vestibular and somatosensory systems. Postural stability is achieved by sensory information about the static or dynamic position of the body resulting in an appropriate motor response. Poor postural stability in individuals with knee osteoarthritis often results in an increased risk of falling and decrease in mobility. It has been reported that 40% of knee osteoarthritis patients fall at least once in a year. Total knee arthroplasty (TKA) is a surgical treatment approach applied to individuals with advanced knee osteoarthritis. It has been shown that this method provides an improvement in the postural stability levels of individuals compared to the preoperative period and a decrease in number of falls reported by the patient. Even if this improvement is achieved, postural stability losses can still be observed in individuals undergoing TKA which affect balance performance.
Obesity is defined by an excessive increase in the ratio of body fat mass relative to lean mass. Individuals with a Body Mass Index (BMI) above 30 kg/m2 are defined as obese. Changes in body composition and increased adiposity rate lead to significant locomotor system problems. A decrease in postural control, increased risk of falling or fear of falling can be defined as locomotor system problems. It has been reported that there is a relationship between increased fat ratio and loss of postural stability in adult obese individuals.
Read more
In a published study, it was reported that as of 2029, 46% of the population in America will be obese or morbidly obese, and 69% of individuals who have undergone total knee arthroplasty surgery will be obese or morbidly obese. Obesity causes several complications such as increased mortality and increase in likelihood of revision surgery that can be seen after total knee arthroplasty. Therefore, it is clinically important to determine the functional status and balance status in order to reduce the possible long-term complications that may develop in the post-operative period and the risk of falling, especially in obese individuals.
The effects of increasing obesity level on postural stability in individuals undergoing total knee arthroplasty are unknown. In this context, the aim of our study is to compare the postural stability levels of normal, overweight and obese individuals who underwent total knee arthroplasty.
- Being tested
- Postural stability measurement, Timed Up and Go test
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural stability measurementOther
Postural stability of the participants will be evaluated with the NeuroCom Balance Master Static Posturography device. Evaluations will be carried out in the presence of two physiotherapists to prevent the patient from falling. Posturography devices allow us to quantitatively evaluate posture and balance and obtain objective results by measuring postural sway.
Timed Up and Go testOther
During the Timed Up and Go test, which is applied to evaluate dynamic balance and performance, the participant is asked to get up from the chair, walk 3 meters and sit back on the chair. The participant's time to complete the test is recorded. Completion of the test for more than 10 seconds indicates an increased risk of falling
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
Postural stability of the participants will be evaluated with the NeuroCom Balance Master Static Posturography device. Posturography devices allow us to quantitatively evaluate posture and balance and obtain objective results by measuring postural sway. Sensory impairment, motor impairment and functional limitations can be evaluated with this device. In the study, the Clinical Test of Sensory Interaction on Balance (mCTSIB) will be used to evaluate the sensory status, and the Limits of Stability-LOS Test, Rhythmic Weight Shift-RWS will be used to evaluate the motor status. The Unilateral Stance-US Test will also be used to evaluate the functional limitation.
Measured: Day 1
Falls Efficacy Scale
Falls Efficacy Scale measures fear of falling during different social or physical activities at home and outside with a scale consisting of 16 questions. The total score ranges from 16 to 64, and a high score indicates greater fear of falling.
Measured: Day 1
Secondary outcomes (3)
Short Physical Performance Battery (SPPB)
SPPB was developed to measure the strength and performance of the lower extremity muscles. Walking speed, standing balance and getting up from a chair for 5 times are the sub-components of this test. For standing balance, the patient will be asked to hold his position for 10 seconds in normal, semi-tandem and tandem foot postures. For walking speed, walking time of 4 m distance will be recorded. Finally, the time the participant sit to stand for 5 times from a chair without arm support will be recorded.
Measured: Day 1
Timed Up and Go Test
The Timed Up and Go test is applied to evaluate dynamic balance and performance. During this test the participant will be asked to get up from the chair, walk 3 meters and sit back on the chair. The participant's time to complete the test is recorded. Completion of the test for more than 10 seconds indicates an increased risk of falling.
Measured: Day 1
Pain Severity
The pain intensity felt by the participants at rest and during movement will be evaluated with the Visual Analog Scale. Visual Analog Scale determines pain severity with a 10 cm horizontal line and "0" indicates no pain, "10" indicates unbearable pain. The point marked by the patient on this line will be measured and recorded with the help of a ruler.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start12 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420194
- Sponsor's protocol ID
- ATADEK -2022/7
- Status last verified
- Aug 2023
- First submitted
- 12 Jun 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postural Stability in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05420194
- Acronym / sponsor ID
- ATADEK -2022/7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Jun 2022 (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.
Postural balance can be described as the integration of the information obtained from visual, vestibular and somatosensory systems. Postural stability is achieved by sensory information about the static or dynamic position of the body resulting in an appropriate motor response. Poor postural stability in individuals with knee osteoarthritis often results in an increased risk of falling and decrease in mobility. It has been reported that 40% of knee osteoarthritis patients fall at least once in a year. Total knee arthroplasty (TKA) is a surgical treatment approach applied to individuals with advanced knee osteoarthritis. It has been shown that this method provides an improvement in the postural stability levels of individuals compared to the preoperative period and a decrease in number of falls reported by the patient. Even if this improvement is achieved, postural stability losses can still be observed in individuals undergoing TKA which affect balance performance.
Obesity is defined by an excessive increase in the ratio of body fat mass relative to lean mass. Individuals with a Body Mass Index (BMI) above 30 kg/m2 are defined as obese. Changes in body composition and increased adiposity rate lead to significant locomotor system problems. A decrease in postural control, increased risk of falling or fear of falling can be defined as locomotor system problems. It has been reported that there is a relationship between increased fat ratio and loss of postural stability in adult obese individuals.
In a published study, it was reported that as of 2029, 46% of the population in America will be obese or morbidly obese, and 69% of individuals who have undergone total knee arthroplasty surgery will be obese or morbidly obese. Obesity causes several complications such as increased mortality and increase in likelihood of revision surgery that can be seen after total knee arthroplasty. Therefore, it is clinically important to determine the functional status and balance status in order to reduce the possible long-term complications that may develop in the post-operative period and the risk of falling, especially in obese individuals.
The effects of increasing obesity level on postural stability in individuals undergoing total knee arthroplasty are unknown. In this context, the aim of our study is to compare the postural stability levels of normal, overweight and obese individuals who underwent total knee arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had undergone total knee arthroplasty
Key inclusion criteria (2 listed)
- Follow-up period is between 1-5 years,
- Volunteer to participate in the study,
Key exclusion criteria (3 listed)
- Having undergone revision surgery on the same or opposite knee after total knee arthroplasty,
- Patients who have undergone total hip replacement.
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 |
|---|---|---|
| Postural stability measurementPostural stability of the participants will be evaluated with the NeuroCom Balance Master Static Posturography device. Evaluations will be carried out in the presence of two physiotherapists to prevent the patient from falling. Posturography devices allow us to quantitatively evaluate posture and balance and obtain objective results by measuring postural sway. | Other | – |
| Timed Up and Go testDuring the Timed Up and Go test, which is applied to evaluate dynamic balance and performance, the participant is asked to get up from the chair, walk 3 meters and sit back on the chair. The participant's time to complete the test is recorded. Completion of the test for more than 10 seconds indicates an increased risk of falling | Other | – |
Primary outcome
Postural Stability
Time frame: Day 1
Postural stability of the participants will be evaluated with the NeuroCom Balance Master Static Posturography device. Posturography devices allow us to quantitatively evaluate posture and balance and obtain objective results by measuring postural sway. Sensory impairment, motor impairment and functional limitations can be evaluated with this device. In the study, the Clinical Test of Sensory Interaction on Balance (mCTSIB) will be used to evaluate the sensory status, and the Limits of Stability-LOS Test, Rhythmic Weight Shift-RWS will be used to evaluate the motor status. The Unilateral Stance-US Test will also be used to evaluate the functional limitation.
Falls Efficacy Scale
Time frame: Day 1
Falls Efficacy Scale measures fear of falling during different social or physical activities at home and outside with a scale consisting of 16 questions. The total score ranges from 16 to 64, and a high score indicates greater fear of falling.
3 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Day 1
Timed Up and Go Test
Time frame: Day 1
Pain Severity
Time frame: Day 1
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 14 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthritis and Arthroplasty Complications, run by Acibadem University at 2 sites 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 2 inclusion and 3 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Postural Stability (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.