Total Knee ArthroplastyNCT05965765
Effection of Total Knee Arthroplasty on Knee Joint
A study testing Total knee arthroplasty and osteoarthritis without surgery in people with Total Knee Arthroplasty, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the joint position sense of individuals diagnosed with knee osteoarthritis and who have undergone unilateral total knee arthroplasty surgery, and to examine the effect of joint position sense on parameters related to balance, physical performance, reaction time, kinesiophobia, pain… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty and osteoarthritis without surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2023to 30 Jul 2023
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- FOR THE GROUP WITH KNEE ARTROPLASTY SURGERY:
- Be over the age of 40
- Having previously undergone unilateral total knee arthroplasty and at least 3 months have passed since
- Volunteer
- FOR GROUP WITH KNEE OSTEOARTHRITIS:
- Be over the age of 40
Show all 12Show fewer
- Being diagnosed with OA clinically and radiologically (Kellgren-Lawrence II-IV)
- Not having been exposed to any surgical intervention for the knee Not having received intra-articular injection of the knee in the last 3 months.
- Volunteer
- FOR THE GROUP OF HEALTHY VOLUNTEERS:
- Be over the age of 40 Not having knee OA or any knee disease No complaints of knee pain in the last 6 months
- Volunteer
Who cannot join
- For all groups:
- Previous knee surgery (People who have undergone replantation surgery)
- Individuals who have had lower extremity surgery
- Pregnancy or lactation Those with lower extremity fractures
- Those with sensory defects
- Those diagnosed with malignancy Those with incompletely healed fractures
Show all 13Show fewer
- Those with circulatory disorders Those who have infection in the areas around the knee joint
- Those with metal implants
- Cancer patients known to be life-threatening
- People with severe hearing loss or visual impairment
- People with communication problems Those with uncontrollably high blood pressure People with vestibular problems such as vertigo and balance problems
- Patients who want to leave the study
- Patients who cannot continue to work due to developing additional disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Knee Joint Position Sense and Balance, Function and Reaction Time After Total Knee Arthroplasty
The aim of this study is to evaluate the joint position sense of individuals diagnosed with knee osteoarthritis and who have undergone unilateral total knee arthroplasty surgery, and to examine the effect of joint position sense on parameters related to balance, physical performance, reaction time, kinesiophobia, pain and stiffness.
Answered the question of the relationship between knee joint position sense, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function in individuals who have undergone knee arthroplasty.
Read more
Answered the question of the relationship between knee joint position sense, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function in individuals diagnosed with knee OA who have not undergone surgery.
Answered the question of whether there is a difference between the knee joint position sense values, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function of individuals who have undergone Knee Arthroplasty, individuals diagnosed with Knee OA and healthy individuals.
Read the detailed description
The aim of this study; To evaluate the joint position sense of individuals who met the inclusion-exclusion criteria of the study by examining the retrospective files of individuals who had previously undergone unilateral total knee arthroplasty surgery due to knee osteoarthritis and whose treatments were completed, and to examine the effect of joint position sense on parameters related to balance, physical performance, reaction time, kinesiophobia, pain and stiffness.It is thought that it will be useful to understand the relationship between the individual's balance, reaction time and physical performance parameters by determining the changes in the joint position sense of individuals who have previously undergone unilateral total knee arthroplasty and individuals with knee osteoarthritis. Also, secondarily; it will shed light on the literature about whether all the evaluated parameters are affected only by the presence of the disease or because of surgery.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty, osteoarthritis without surgery, control group
- Keywords
- Arthroplasty, Equilibrium, Knee, Knee joint, Knee prosthesis, Recovery of function, Osteoarthritis, Osteoarthritis-knee, Proprioception, Reaction time
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDiagnostic test
who got total knee arthroplasty because of osteoarthritis
osteoarthritis without surgeryDiagnostic test
who has osteoarthritis and didn't get any surgery
control groupDiagnostic test
healthy people
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Experimental | Individuals who have previously undergone Unilateral total knee arthroplasty Receives: Diagnostic Test: Total knee arthroplasty |
| Osteoarthritis without surgery | Experimental | According to Kellgren-Lawrence, individuals diagnosed with osteoarthritis between II and IV Receives: Diagnostic Test: osteoarthritis without surgery |
| Control Group | Active comparator | healthy individuals who have not had any knee problems in the last 6 months Receives: Diagnostic Test: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Position Sense
Knee joint position sense will be evaluated with the mobile application. As the target angle, 15˚, 45˚ and 60˚ knee flexion positions will be determined. For the initial target angle of 15˚ knee flexion, the physiotherapist will passively bring the individual's knee to 15˚ knee flexion and remain in this position for 5 seconds. The individual will be asked to feel and remember this angle, and when he thinks he has come to this angle during the test, he will be asked to say "here" by keeping his knee fixed at that angle. The "estimated target angle" that the person perceives as the "target angle" will be recorded with the phone application. For a target angle, the average of the 3 measurements will be recorded. The deviation angle between the taught target angle and the estimated target angle made by the individual will be calculated.
Measured: baseline
Balance
Berg Balance scale, which has Turkish validity and reliability, will be used in the evaluation of balance. Scale; It consists of 14 parameters that evaluate sitting, standing and standing. These parameters are scored between 0 (unable) and 4 (doing safely). The maximum score is 56. As the score decreases, it will be interpreted as the risk of falling increases and the balance is poor.
Measured: baseline
Reaction Time
Nelson Foot Reaction Test will be used to evaluate the reaction rate. Individuals will be asked to remove their shoes and sit on the stool. The dominant side will be positioned so that the toe is 2.5 cm away from the wall and the heel is 5 cm away from the wall. The observer will hold the 30 cm long wooden ruler on the wall and at the level of the dominant toe of the individual to be evaluated, count backwards from three, one by one and say zero, and leave the ruler. The individual will be asked to hold the falling ruler with the toe and the value on the tip of the foot at the moment he catches the ruler will be recorded in centimeters. The test will be repeated 5 times, and the average of the 3 values other than the lowest and highest values will be recorded in centimeters. The average value obtained will be put into the formula "Reaction Time= √2 x Distance (cm)/980 cm/s2" and the reaction time will be calculated and recorded in seconds.
Measured: baseline
Physical Performance
Timed Up \& Go Test (TIGT): This test is frequently used in the evaluation of functional status in individuals with OA and its original name is "Timed Up \& Go Test" (TUG). During this test, individuals will be asked to get up from a chair with fixed arms while sitting with their feet in contact with the floor, walk 3 meters, return from the marked place at the end of 3 meters, walk back to the chair and sit on the chair. The duration will be started as soon as the hips of the individuals are out of contact with the chair and stopped when their hips come into contact with the chair after they return, and will be recorded in seconds with a stopwatch.
Measured: baseline
Kinesiophobia
Tampa Kinesiophobia Scale will be used in the evaluation of kinesiophobia. The Tampa Kinesiophobia Scale is a 17-question checklist. It is scored between 1 and 4 points on a Likert scale (1 answer I strongly disagree, 4 answer I strongly agree), 4,8,12,16. The calculation of the questions is done by inverting. The score is determined in the range of 17-68 points, and as the score increases, the fear of movement also increases.
Measured: baseline
Evaluation of Pain, Function, and Stiffness
WOMAC index in order to determine the severity of the clinical findings in the cases and the effects of the current clinical picture on the daily living activities of the patients; osteoarthritis index will be evaluated. WOMAC consists of 3 parts and 24 questions. There are 5 questions in the pain section, 2 questions in the stiffness section, and 17 questions in the physical function section. The total WOMAC value will be obtained by scoring the answers given by the patients as none/mild/moderate/severe/extreme, respectively, between 0 and 4 points. Then, the scores of each section will be collected within itself and the score for that section will be found. High WOMAC values indicate an increase in pain and stiffness and deterioration in physical function. As a result of the study examining the acceptability, reliability, validity and sensitivity of the Turkish version of the WOMAC OA index, it was shown that the Turkish version of the WOMAC index had good content validity.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start4 May 2023
- Primary completion20 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nihal Yurttaş, KTO Karatay University
- Investigators
- Ayşe Nihal YURTTAŞ, master, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965765
- Sponsor's protocol ID
- E-41901325-200-57879
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yurttas AN, Araci A, Akkoyun Sert O, Ismayilov T. Investigation of knee joint position sensation balance reaction time and function in individuals with knee osteoarthritis and unilateral total knee arthroplasty. J Back Musculoskelet Rehabil. 2026 Mar;39(2):619-628. doi: 10.1177/10538127251387392. Epub 2025 Oct 27.
PubMed 41143951
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Knee Joint Position Sense and Balance, Function and Reaction Time After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05965765
- Acronym / sponsor ID
- E-41901325-200-57879
- Conditions
- Total Knee Arthroplasty
- Keywords
- Arthroplasty, Equilibrium, Knee, Knee joint, Knee prosthesis, Recovery of function, Osteoarthritis, Osteoarthritis-knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 28 Jul 2023 (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.
The aim of this study is to evaluate the joint position sense of individuals diagnosed with knee osteoarthritis and who have undergone unilateral total knee arthroplasty surgery, and to examine the effect of joint position sense on parameters related to balance, physical performance, reaction time, kinesiophobia, pain and stiffness.
Answered the question of the relationship between knee joint position sense, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function in individuals who have undergone knee arthroplasty.
Answered the question of the relationship between knee joint position sense, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function in individuals diagnosed with knee OA who have not undergone surgery.
Answered the question of whether there is a difference between the knee joint position sense values, balance, physical performance, reaction time, kinesiophobia levels, pain, stiffness and function of individuals who have undergone Knee Arthroplasty, individuals diagnosed with Knee OA and healthy individuals.
Detailed description
The aim of this study; To evaluate the joint position sense of individuals who met the inclusion-exclusion criteria of the study by examining the retrospective files of individuals who had previously undergone unilateral total knee arthroplasty surgery due to knee osteoarthritis and whose treatments were completed, and to examine the effect of joint position sense on parameters related to balance, physical performance, reaction time, kinesiophobia, pain and stiffness.It is thought that it will be useful to understand the relationship between the individual's balance, reaction time and physical performance parameters by determining the changes in the joint position sense of individuals who have previously undergone unilateral total knee arthroplasty and individuals with knee osteoarthritis. Also, secondarily; it will shed light on the literature about whether all the evaluated parameters are affected only by the presence of the disease or because of surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | Experimental | Diagnostic Test: Total knee arthroplastyIndividuals who have previously undergone Unilateral total knee arthroplasty |
| Osteoarthritis without surgery | Experimental | Diagnostic Test: osteoarthritis without surgeryAccording to Kellgren-Lawrence, individuals diagnosed with osteoarthritis between II and IV |
| Control Group | Active comparator | Diagnostic Test: control grouphealthy individuals who have not had any knee problems in the last 6 months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- FOR THE GROUP WITH KNEE ARTROPLASTY SURGERY:
- FOR GROUP WITH KNEE OSTEOARTHRITIS:
- FOR THE GROUP OF HEALTHY VOLUNTEERS:
Key exclusion criteria (13 listed)
- For all groups:
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 |
|---|---|---|
| Total knee arthroplastywho got total knee arthroplasty because of osteoarthritis | Diagnostic test | Total Knee Arthroplasty |
| osteoarthritis without surgerywho has osteoarthritis and didn't get any surgery | Diagnostic test | Osteoarthritis without surgery |
| control grouphealthy people | Diagnostic test | Control Group |
Primary outcome
Knee Position Sense
Time frame: baseline
Knee joint position sense will be evaluated with the mobile application. As the target angle, 15˚, 45˚ and 60˚ knee flexion positions will be determined. For the initial target angle of 15˚ knee flexion, the physiotherapist will passively bring the individual's knee to 15˚ knee flexion and remain in this position for 5 seconds. The individual will be asked to feel and remember this angle, and when he thinks he has come to this angle during the test, he will be asked to say "here" by keeping his knee fixed at that angle. The "estimated target angle" that the person perceives as the "target angle" will be recorded with the phone application. For a target angle, the average of the 3 measurements will be recorded. The deviation angle between the taught target angle and the estimated target angle made by the individual will be calculated.
Balance
Time frame: baseline
Berg Balance scale, which has Turkish validity and reliability, will be used in the evaluation of balance. Scale; It consists of 14 parameters that evaluate sitting, standing and standing. These parameters are scored between 0 (unable) and 4 (doing safely). The maximum score is 56. As the score decreases, it will be interpreted as the risk of falling increases and the balance is poor.
Reaction Time
Time frame: baseline
Nelson Foot Reaction Test will be used to evaluate the reaction rate. Individuals will be asked to remove their shoes and sit on the stool. The dominant side will be positioned so that the toe is 2.5 cm away from the wall and the heel is 5 cm away from the wall. The observer will hold the 30 cm long wooden ruler on the wall and at the level of the dominant toe of the individual to be evaluated, count backwards from three, one by one and say zero, and leave the ruler. The individual will be asked to hold the falling ruler with the toe and the value on the tip of the foot at the moment he catches the ruler will be recorded in centimeters. The test will be repeated 5 times, and the average of the 3 values other than the lowest and highest values will be recorded in centimeters. The average value obtained will be put into the formula "Reaction Time= √2 x Distance (cm)/980 cm/s2" and the reaction time will be calculated and recorded in seconds.
Physical Performance
Time frame: baseline
Timed Up \& Go Test (TIGT): This test is frequently used in the evaluation of functional status in individuals with OA and its original name is "Timed Up \& Go Test" (TUG). During this test, individuals will be asked to get up from a chair with fixed arms while sitting with their feet in contact with the floor, walk 3 meters, return from the marked place at the end of 3 meters, walk back to the chair and sit on the chair. The duration will be started as soon as the hips of the individuals are out of contact with the chair and stopped when their hips come into contact with the chair after they return, and will be recorded in seconds with a stopwatch.
Kinesiophobia
Time frame: baseline
Tampa Kinesiophobia Scale will be used in the evaluation of kinesiophobia. The Tampa Kinesiophobia Scale is a 17-question checklist. It is scored between 1 and 4 points on a Likert scale (1 answer I strongly disagree, 4 answer I strongly agree), 4,8,12,16. The calculation of the questions is done by inverting. The score is determined in the range of 17-68 points, and as the score increases, the fear of movement also increases.
Evaluation of Pain, Function, and Stiffness
Time frame: baseline
WOMAC index in order to determine the severity of the clinical findings in the cases and the effects of the current clinical picture on the daily living activities of the patients; osteoarthritis index will be evaluated. WOMAC consists of 3 parts and 24 questions. There are 5 questions in the pain section, 2 questions in the stiffness section, and 17 questions in the physical function section. The total WOMAC value will be obtained by scoring the answers given by the patients as none/mild/moderate/severe/extreme, respectively, between 0 and 4 points. Then, the scores of each section will be collected within itself and the score for that section will be found. High WOMAC values indicate an increase in pain and stiffness and deterioration in physical function. As a result of the study examining the acceptability, reliability, validity and sensitivity of the Turkish version of the WOMAC OA index, it was shown that the Turkish version of the WOMAC index had good content validity.
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 11 Feb 2025.
- Derived from this study: PubMed 41143951Yurttas AN, Araci A, Akkoyun Sert O, Ismayilov T. Investigation of knee joint position sensation balance reaction time and function in individuals with knee osteoarthritis and unilateral total knee arthroplasty. J Back Musculoskelet Rehabil. 2026 Mar;39(2):619-628. doi: 10.1177/10538127251387392. Epub 2025 Oct 27.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Ayşe Nihal YURTTAŞ, master principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty and osteoarthritis without surgery in people with Total Knee Arthroplasty, run by KTO Karatay 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 12 inclusion and 13 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 11 Feb 2025. 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?
Knee Position Sense (time frame: baseline). The study lists 6 primary outcomes in all. 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 NCT05965765, which also lists 1 linked publication.
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 11 Feb 2025.