Knee OsteoarthritisNCT06701474
Comparison of Functional Recovery After Total Knee Arthroplasty Between Low Phase Angle and High Phase Angle Group
An observational study of Knee Osteoarthritis, run by Yonsei University at 1 site in South Korea.
Trial summary
The goal of this observational study is to compare the functional outcome of patients with end-stage knee osteoarthritis (OA) before and after total knee arthroplasty based on the phase angle level. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2024to 23 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single general hospital
Who may be able to join
- Individuals aged 55 and over (based on the age on their national ID at the time of consent)
- Individuals diagnosed with knee OA based on medical history, physical examination, and radiographic assessments.
- Individuals who plan to perform total knee arthroplasty
Who cannot join
- Individuals with gait disturbance due to neurologic disorders such as Parkinson disease, stroke and dementia
- Individuals with severe cardiac, pulmonary, or musculoskeletal disorders that limited quadriceps strength and physical function
- Individuals with knee osteoarthritis due to secondary causes such as rheumatic or traumatic arthritis
- Individuals with a history of any knee surgery within one year.
- Individuals considered clinically unsuitable for the study by the researchers or person in charge based on significant medical findings.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
Na Young Kim, MD, PhD, +82 010 9127 4482, kny8452@yuhs.ac
Young Seok Kim, MD, +82 010 7225 3661, kys3661@yuhs.ac
About this study
Official title: Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty
The goal of this observational study is to compare the functional outcome of patients with end-stage knee osteoarthritis (OA) before and after total knee arthroplasty based on the phase angle level.
The main questions it aims to answer are:
Read more
- Do patients with low phase angle show worse functional recovery after total knee arthroplasty compared to those with high phase angle?
- Is postoperative physical function associated with preoperative phase angle level?
Researchers will compare postoperative physical function and muscle strength between the low and high phase angle groups to determine whether a low phase angle is associated with poorer functional recovery.
Participants will:
Perform physical function tests, isokinetic strength assessments, and bioelectrical impedance analysis before and three months after surgery.
Read the detailed description
After obtaining informed consent, a pre-surgical screening is conducted. Participants complete a history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).
The screening includes a comprehensive evaluation of baseline symptoms, followed by functional assessments that incorporate bioelectrical impedance analysis, muscle strength testing, and performance-based tests:
- A modified Charlson Comorbidity Index (CCI) is used to assess comorbidity burden, and a Numeric Pain Rating Scale (NPRS) records participants' initial pain levels.
- Radiographic assessments are performed to evaluate the frontal alignment of the lower extremities and the radiographic severity of knee osteoarthritis (OA) using the Kellgren-Lawrence (K-L) grading system.
- Multifrequency bioelectrical impedance analysis (BIA) is used to measure phase angle and body composition.
- Handgrip strength is measured through three trials on each side, with the average recorded.
- Knee strength is measured using an isokinetic dynamometer.
- Performance-based tests include the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale (BBS).
Follow-up assessments are conducted three months after total knee arthroplasty, with participants undergoing the same protocol for performance-based tests, isokinetic knee strength evaluation, and bioelectrical impedance analysis.
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, phase angle, sarcopenia, bioelectrical impedance
- Medical subject headings
- Osteoarthritis, Knee, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high PhA | * Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty. * Among these, patients are classified into the high PhA group if their preoperative PhA is above 4.95 for males or 4.35 for females | |
| low PhA | * Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty. * Among these, patients are classified into the low PhA group if their preoperative PhA is below 4.95 for males or 4.35 for females |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test (TUG)
Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back.
The average time of three trials was recorded as a result
Measured: Baseline and 3 months after surgery
10 meter walk test (10MWT)
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed.
Gait speed was calculated by dividing the 10m distance by the time taken.
Measured: Baseline and 3 months after surgery
Berg balance scale (BBS)
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
Measured: Baseline and 3 months after surgery
Secondary outcomes (9)
Isokinetic peak torque of knee flexion at 60°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the peak flexion torque is performed at preset constant angular velocities, 60°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic peak torque of knee flexion at 150°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the peak flexion torque is performed at preset constant angular velocities, 150°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic peak torque of knee extension at 60°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the peak extension torque is performed at preset constant angular velocities, 60°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic peak torque of knee extension at 150°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the peak extension torque is performed at preset constant angular velocities, 150°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic total work of knee flexion at 60°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the total knee flexion effort is performed at preset constant angular velocities, 60°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic total work of knee flexion at 150°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the total knee flexion effort is performed at preset constant angular velocities, 150°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic total work of knee extension at 60°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the total knee extension effort is performed at preset constant angular velocities, 60°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Isokinetic total work of knee extension at 150°/s
- Isokinetic knee assessment is assessed using an isokinetic dynamometer (Cybex NORM®, Humac, CA, USA).
- Each participant is positioned on an adjustable chair and secured to the equipment with straps across the trunk, hip, and thigh.
- Gravity correction measurements are made according to the manufacturer's instructions.
- Participants are instructed on standardized procedures before and during the test.
- Concentric measurement of the total knee extension effort is performed at preset constant angular velocities, 150°/s, with a rest period between each trial to prevent fatigue and ensure consistent effort levels.
- Participants warm up with five to six submaximal practice repetitions before each test series. After repeating three times, the examiner records the average value.
Measured: Baseline and 3 months after surgery
Whole body phase angle at 50kHz
- Whole body phase angle is calculated using the multifrequency Bioelectrical impedance analysis (BIA) with the InBody S10 (BioSpace, Seoul, Korea).
- Before measurement, all patients are asked to fast for a minimum of 3 hours with the bladder emptied and avoid alcohol or vigorous activity.
- Tetrapolar 8-point electrodes are placed on the dorsal surfaces of both wrist and foot according to the manufacturer's instruction.
- After resting for 15 minutes, a weak current under 100uA is applied to measure the reactance (Xc) and impedance (R) of 6 Different Frequencies (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz).
- A whole body Phase angle is calculated as an arctangent of the Xc to R ratio at 50kHz. [Phase angle (degrees) arctan(Xc/R) (180/π)]
Measured: Baseline and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start13 Sep 2024
- Primary completion23 Sep 2025 (estimated)
- Study completion23 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701474
- Sponsor's protocol ID
- 9-2024-0150
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uemura K, Doi T, Tsutsumimoto K, Nakakubo S, Kim MJ, Kurita S, Ishii H, Shimada H. Predictivity of bioimpedance phase angle for incident disability in older adults. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):46-54. doi: 10.1002/jcsm.12492. Epub 2019 Aug 22.
PubMed 31436391Martins PC, Alves Junior CAS, Silva AM, Silva DAS. Phase angle and body composition: A scoping review. Clin Nutr ESPEN. 2023 Aug;56:237-250. doi: 10.1016/j.clnesp.2023.05.015. Epub 2023 Jun 1.
PubMed 37344079Stapel SN, Looijaard WGPM, Dekker IM, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Bioelectrical impedance analysis-derived phase angle at admission as a predictor of 90-day mortality in intensive care patients. Eur J Clin Nutr. 2018 Jul;72(7):1019-1025. doi: 10.1038/s41430-018-0167-1. Epub 2018 May 11.
PubMed 29748659Sardinha LB, Rosa GB. Phase angle, muscle tissue, and resistance training. Rev Endocr Metab Disord. 2023 Jun;24(3):393-414. doi: 10.1007/s11154-023-09791-8. Epub 2023 Feb 10.
PubMed 36759377Harris IA, Harris AM, Naylor JM, Adie S, Mittal R, Dao AT. Discordance between patient and surgeon satisfaction after total joint arthroplasty. J Arthroplasty. 2013 May;28(5):722-7. doi: 10.1016/j.arth.2012.07.044. Epub 2013 Feb 23.
PubMed 23462496Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Capin JJ, Bade MJ, Jennings JM, Snyder-Mackler L, Stevens-Lapsley JE. Total Knee Arthroplasty Assessments Should Include Strength and Performance-Based Functional Tests to Complement Range-of-Motion and Patient-Reported Outcome Measures. Phys Ther. 2022 Jun 3;102(6):pzac033. doi: 10.1093/ptj/pzac033.
PubMed 35358318Wieczorek M, Rotonda C, Guillemin F, Rat AC. What Have We Learned About the Course of Clinical Outcomes After Total Knee or Hip Arthroplasty? Arthritis Care Res (Hoboken). 2020 Nov;72(11):1519-1529. doi: 10.1002/acr.24045.
PubMed 31421025GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
PubMed 37675071
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Phase Angle and Functional Recovery After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06701474
- Acronym / sponsor ID
- 9-2024-0150
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, phase angle, sarcopenia, bioelectrical impedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 23 Sep 2025 (estimated)
- Study completion
- 23 Sep 2025 (estimated)
- First posted
- 22 Nov 2024 (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 goal of this observational study is to compare the functional outcome of patients with end-stage knee osteoarthritis (OA) before and after total knee arthroplasty based on the phase angle level.
The main questions it aims to answer are:
- Do patients with low phase angle show worse functional recovery after total knee arthroplasty compared to those with high phase angle?
- Is postoperative physical function associated with preoperative phase angle level?
Researchers will compare postoperative physical function and muscle strength between the low and high phase angle groups to determine whether a low phase angle is associated with poorer functional recovery.
Participants will:
Perform physical function tests, isokinetic strength assessments, and bioelectrical impedance analysis before and three months after surgery.
Detailed description
After obtaining informed consent, a pre-surgical screening is conducted. Participants complete a history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).
The screening includes a comprehensive evaluation of baseline symptoms, followed by functional assessments that incorporate bioelectrical impedance analysis, muscle strength testing, and performance-based tests:
- A modified Charlson Comorbidity Index (CCI) is used to assess comorbidity burden, and a Numeric Pain Rating Scale (NPRS) records participants' initial pain levels.
- Radiographic assessments are performed to evaluate the frontal alignment of the lower extremities and the radiographic severity of knee osteoarthritis (OA) using the Kellgren-Lawrence (K-L) grading system.
- Multifrequency bioelectrical impedance analysis (BIA) is used to measure phase angle and body composition.
- Handgrip strength is measured through three trials on each side, with the average recorded.
- Knee strength is measured using an isokinetic dynamometer.
- Performance-based tests include the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale (BBS).
Follow-up assessments are conducted three months after total knee arthroplasty, with participants undergoing the same protocol for performance-based tests, isokinetic knee strength evaluation, and bioelectrical impedance analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high PhA | – | –* Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty. * Among these, patients are classified into the high PhA group if their preoperative PhA is above 4.95 for males or 4.35 for females |
| low PhA | – | –* Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty. * Among these, patients are classified into the low PhA group if their preoperative PhA is below 4.95 for males or 4.35 for females |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single general hospital
Key inclusion criteria (3 listed)
- Individuals aged 55 and over (based on the age on their national ID at the time of consent)
- Individuals diagnosed with knee OA based on medical history, physical examination, and radiographic assessments.
- Individuals who plan to perform total knee arthroplasty
Key exclusion criteria (5 listed)
- Individuals with gait disturbance due to neurologic disorders such as Parkinson disease, stroke and dementia
- Individuals with severe cardiac, pulmonary, or musculoskeletal disorders that limited quadriceps strength and physical function
- Individuals with knee osteoarthritis due to secondary causes such as rheumatic or traumatic arthritis
- Individuals with a history of any knee surgery within one year.
- Individuals considered clinically unsuitable for the study by the researchers or person in charge based on significant medical findings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Timed up and go test (TUG)
Time frame: Baseline and 3 months after surgery
Researchers ask patients to rise from a seated position, walk a distance of 3 m, turn around, return to the chair, and sit back. The average time of three trials was recorded as a result
10 meter walk test (10MWT)
Time frame: Baseline and 3 months after surgery
Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.
Berg balance scale (BBS)
Time frame: Baseline and 3 months after surgery
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
9 secondary outcomes
Isokinetic peak torque of knee flexion at 60°/s
Time frame: Baseline and 3 months after surgery
Isokinetic peak torque of knee flexion at 150°/s
Time frame: Baseline and 3 months after surgery
Isokinetic peak torque of knee extension at 60°/s
Time frame: Baseline and 3 months after surgery
Isokinetic peak torque of knee extension at 150°/s
Time frame: Baseline and 3 months after surgery
Isokinetic total work of knee flexion at 60°/s
Time frame: Baseline and 3 months after surgery
Isokinetic total work of knee flexion at 150°/s
Time frame: Baseline and 3 months after surgery
Isokinetic total work of knee extension at 60°/s
Time frame: Baseline and 3 months after surgery
Isokinetic total work of knee extension at 150°/s
Time frame: Baseline and 3 months after surgery
Whole body phase angle at 50kHz
Time frame: Baseline and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Results publication: PubMed 31436391Uemura K, Doi T, Tsutsumimoto K, Nakakubo S, Kim MJ, Kurita S, Ishii H, Shimada H. Predictivity of bioimpedance phase angle for incident disability in older adults. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):46-54. doi: 10.1002/jcsm.12492. Epub 2019 Aug 22.
- Results publication: PubMed 37344079Martins PC, Alves Junior CAS, Silva AM, Silva DAS. Phase angle and body composition: A scoping review. Clin Nutr ESPEN. 2023 Aug;56:237-250. doi: 10.1016/j.clnesp.2023.05.015. Epub 2023 Jun 1.
- Results publication: PubMed 29748659Stapel SN, Looijaard WGPM, Dekker IM, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Bioelectrical impedance analysis-derived phase angle at admission as a predictor of 90-day mortality in intensive care patients. Eur J Clin Nutr. 2018 Jul;72(7):1019-1025. doi: 10.1038/s41430-018-0167-1. Epub 2018 May 11.
- Results publication: PubMed 36759377Sardinha LB, Rosa GB. Phase angle, muscle tissue, and resistance training. Rev Endocr Metab Disord. 2023 Jun;24(3):393-414. doi: 10.1007/s11154-023-09791-8. Epub 2023 Feb 10.
- Results publication: PubMed 23462496Harris IA, Harris AM, Naylor JM, Adie S, Mittal R, Dao AT. Discordance between patient and surgeon satisfaction after total joint arthroplasty. J Arthroplasty. 2013 May;28(5):722-7. doi: 10.1016/j.arth.2012.07.044. Epub 2013 Feb 23.
- Results publication: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Results publication: PubMed 35358318Capin JJ, Bade MJ, Jennings JM, Snyder-Mackler L, Stevens-Lapsley JE. Total Knee Arthroplasty Assessments Should Include Strength and Performance-Based Functional Tests to Complement Range-of-Motion and Patient-Reported Outcome Measures. Phys Ther. 2022 Jun 3;102(6):pzac033. doi: 10.1093/ptj/pzac033.
- Results publication: PubMed 31421025Wieczorek M, Rotonda C, Guillemin F, Rat AC. What Have We Learned About the Course of Clinical Outcomes After Total Knee or Hip Arthroplasty? Arthritis Care Res (Hoboken). 2020 Nov;72(11):1519-1529. doi: 10.1002/acr.24045.
- Results publication: PubMed 37675071GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Young Kim, MD, PhD (+82 010 9127 4482, kny8452@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (TUG) (time frame: Baseline and 3 months after surgery). The study lists 3 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 NCT06701474, which also lists 9 linked publications.
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 7 Feb 2025.