Knee OsteoarthritisNCT07367789
Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by Yonsei University at 1 site in South Korea.
Trial summary
This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Instrumented Insole Gait Assessment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Dec 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with knee osteoarthritis undergoing primary total knee arthroplasty at two hospitals in South Korea.
Who may be able to join
- Age ≥ 19 years
- Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 1-4)
- Scheduled for primary Total Knee Arthroplasty (TKA) at either study site
- Able to walk independently on level ground (Functional Ambulation Categories, FAC ≥ 3)
Who cannot join
- Cancellation of scheduled TKA
- History of TKA on the same knee
- Neurological or musculoskeletal disorders affecting gait
- Pregnancy or possibility of pregnancy
- Any condition deemed inappropriate for study participation by the investigator
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
Seung Ick Choi, +82 010 8821 5297, rehab1@yuhs.ac
About this study
Official title: Prediction of Patient-reported Outcome Measure and Performance-based Measure After Total Knee Arthroplasty Using Instrumented Insoles and Deep Neural Networks
This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA). Participants will undergo standardized gait assessments using instrumented insoles and complete validated patient-reported outcome measures (PROMs). Prediction models including linear regression, random forest, and deep neural networks will be applied and their performance compared.
Read the detailed description
This study investigates predictive factors associated with postoperative improvement in both patient-reported outcomes and performance-based mobility measures among individuals undergoing total knee arthroplasty. Participants from two centers-Yongin Severance Hospital and Gachon University Gil Medical Center-will undergo preoperative collection of demographic data, body composition, muscle strength, comorbidity profiles, radiographic Kellgren-Lawrence grade, and wearable insole-derived gait data during the Timed Up and Go Test (TUGT). Postoperative outcomes at six weeks will include Western Ontario and McMaster Universities Arthritis Index (WOMAC) and TUGT.
Prediction models (linear regression, random forest, and deep neural network models) will be applied using consistent input variables. Model performance will be evaluated using accuracy and Receiver Operating Characteristic-Area Under the Curve (ROC-AUC). This study does not involve any therapeutic intervention and poses minimal risk.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Instrumented Insole Gait Assessment
- Keywords
- Total knee arthroplasty, Prediction model, Deep neural network, Instrumented insole
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented Insole Gait AssessmentOther
Participants undergo gait assessment using an instrumented insole system during the Timed Up and Go Test. The device is used solely for data collection and does not provide therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| TKA Patients | Participants scheduled for primary unilateral total knee arthroplasty at either Yongin Severance Hospital or Gachon University Gil Medical Center. No intervention is assigned; all data are collected as part of observational evaluation. Receives: Other: Instrumented Insole Gait Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement
Improvement in patient-reported symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
The WOMAC is a validated patient-reported outcome measure consisting of 24 items assessing pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale (0-4), resulting in a total score ranging from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation, and lower scores indicate better clinical status.
Postoperative improvement is defined as a decrease of ≥15 points in the WOMAC total score compared with the preoperative baseline, corresponding to the minimal clinically important difference (MCID). Participants will be classified as "improved" or "not improved" based on this criterion (binary outcome).
Measured: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months
Secondary outcomes (1)
Timed Up and Go Test (TUGT) Improvement
Improvement defined as a decrease in TUGT completion time from baseline (binary).
Measured: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Investigators
- Na Young Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367789
- Sponsor's protocol ID
- GBIRB2025-324
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srivastava AK; Surgical Management of Osteoarthritis of the Knee Work Group, Staff of the American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee. J Am Acad Orthop Surg. 2023 Dec 15;31(24):1211-1220. doi: 10.5435/JAAOS-D-23-00338. Epub 2023 Oct 24.
PubMed 37883429Small SR, Bullock GS, Khalid S, Barker K, Trivella M, Price AJ. Current clinical utilisation of wearable motion sensors for the assessment of outcome following knee arthroplasty: a scoping review. BMJ Open. 2019 Dec 29;9(12):e033832. doi: 10.1136/bmjopen-2019-033832.
PubMed 31888943Ferreira AM, Salim R, Fogagnolo F, de Oliveira LFL, Riberto M, Kfuri M. The Value of a Standardized Knee Functional Assessment in Predicting the Outcomes of Total Knee Arthroplasty. J Knee Surg. 2022 Aug;35(10):1126-1131. doi: 10.1055/s-0040-1722321. Epub 2021 Jan 28.
PubMed 33511585Boekesteijn R, Smolders J, Busch V, Keijsers N, Geurts A, Smulders K. Objective monitoring of functional recovery after total knee and hip arthroplasty using sensor-derived gait measures. PeerJ. 2022 Sep 28;10:e14054. doi: 10.7717/peerj.14054. eCollection 2022.
PubMed 36193431Hsieh CY, Huang HY, Liu KC, Chen KH, Hsu SJ, Chan CT. Subtask Segmentation of Timed Up and Go Test for Mobility Assessment of Perioperative Total Knee Arthroplasty. Sensors (Basel). 2020 Nov 5;20(21):6302. doi: 10.3390/s20216302.
PubMed 33167444Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x.
PubMed 12880577Tolk JJ, Janssen RPA, Prinsen CAC, Latijnhouwers DAJM, van der Steen MC, Bierma-Zeinstra SMA, Reijman M. The OARSI core set of performance-based measures for knee osteoarthritis is reliable but not valid and responsive. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2898-2909. doi: 10.1007/s00167-017-4789-y. Epub 2017 Nov 11.
PubMed 29128879Wilfong JM, Badley EM, Power JD, Gandhi R, Rampersaud YR, Perruccio AV. Discordance between self-reported and performance-based function among knee osteoarthritis surgical patients: Variations by sex and obesity. PLoS One. 2020 Jul 30;15(7):e0236865. doi: 10.1371/journal.pone.0236865. eCollection 2020.
PubMed 32730319Cooper NA, Rakel BA, Zimmerman B, Tonelli SM, Herr KA, Clark CR, Noiseux NO, Callaghan JJ, Sluka KA. Predictors of multidimensional functional outcomes after total knee arthroplasty. J Orthop Res. 2017 Dec;35(12):2790-2798. doi: 10.1002/jor.23596. Epub 2017 May 23.
PubMed 28471509Young-Shand KL, Dunbar MJ, Astephen Wilson JL. Individual Gait Features Are Associated with Clinical Improvement After Total Knee Arthroplasty. JB JS Open Access. 2020 Apr 6;5(2):e0038. doi: 10.2106/JBJS.OA.19.00038. eCollection 2020 Apr-Jun.
PubMed 33123659Batailler C, Lording T, De Massari D, Witvoet-Braam S, Bini S, Lustig S. Predictive Models for Clinical Outcomes in Total Knee Arthroplasty: A Systematic Analysis. Arthroplast Today. 2021 Apr 24;9:1-15. doi: 10.1016/j.artd.2021.03.013. eCollection 2021 Jun.
PubMed 33997202Olsen U, Lindberg MF, Rose C, Denison E, Gay C, Aamodt A, Brox JI, Skare O, Furnes O, Lee K, Lerdal A. Factors Correlated With Physical Function 1 Year After Total Knee Arthroplasty in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Jul 1;5(7):e2219636. doi: 10.1001/jamanetworkopen.2022.19636.
PubMed 35816307Harmelink KEM, Zeegers AVCM, Hullegie W, Hoogeboom TJ, Nijhuis-van der Sanden MWG, Staal JB. Are There Prognostic Factors for One-Year Outcome After Total Knee Arthroplasty? A Systematic Review. J Arthroplasty. 2017 Dec;32(12):3840-3853.e1. doi: 10.1016/j.arth.2017.07.011. Epub 2017 Aug 1.
PubMed 28927646Kluge F, Hannink J, Pasluosta C, Klucken J, Gassner H, Gelse K, Eskofier BM, Krinner S. Pre-operative sensor-based gait parameters predict functional outcome after total knee arthroplasty. Gait Posture. 2018 Oct;66:194-200. doi: 10.1016/j.gaitpost.2018.08.026. Epub 2018 Aug 24.
PubMed 30199778Berman AT, Quinn RH, Zarro VJ. Quantitative gait analysis in unilateral and bilateral total hip replacements. Arch Phys Med Rehabil. 1991 Mar;72(3):190-4.
PubMed 1998452
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Patient-reported Outcome Measure and Performance-based Measure After Total Knee Arthroplasty Using Instrumented Insoles and Deep Neural Networks
- ClinicalTrials.gov ID
- NCT07367789
- Acronym / sponsor ID
- GBIRB2025-324
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Prediction model, Deep neural network, Instrumented insole
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA). Participants will undergo standardized gait assessments using instrumented insoles and complete validated patient-reported outcome measures (PROMs). Prediction models including linear regression, random forest, and deep neural networks will be applied and their performance compared.
Detailed description
This study investigates predictive factors associated with postoperative improvement in both patient-reported outcomes and performance-based mobility measures among individuals undergoing total knee arthroplasty. Participants from two centers-Yongin Severance Hospital and Gachon University Gil Medical Center-will undergo preoperative collection of demographic data, body composition, muscle strength, comorbidity profiles, radiographic Kellgren-Lawrence grade, and wearable insole-derived gait data during the Timed Up and Go Test (TUGT). Postoperative outcomes at six weeks will include Western Ontario and McMaster Universities Arthritis Index (WOMAC) and TUGT.
Prediction models (linear regression, random forest, and deep neural network models) will be applied using consistent input variables. Model performance will be evaluated using accuracy and Receiver Operating Characteristic-Area Under the Curve (ROC-AUC). This study does not involve any therapeutic intervention and poses minimal risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA Patients | – | Other: Instrumented Insole Gait AssessmentParticipants scheduled for primary unilateral total knee arthroplasty at either Yongin Severance Hospital or Gachon University Gil Medical Center. No intervention is assigned; all data are collected as part of observational evaluation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with knee osteoarthritis undergoing primary total knee arthroplasty at two hospitals in South Korea.
Key inclusion criteria (4 listed)
- Age ≥ 19 years
- Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 1-4)
- Scheduled for primary Total Knee Arthroplasty (TKA) at either study site
- Able to walk independently on level ground (Functional Ambulation Categories, FAC ≥ 3)
Key exclusion criteria (5 listed)
- Cancellation of scheduled TKA
- History of TKA on the same knee
- Neurological or musculoskeletal disorders affecting gait
- Pregnancy or possibility of pregnancy
- Any condition deemed inappropriate for study participation by the investigator
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 |
|---|---|---|
| Instrumented Insole Gait AssessmentParticipants undergo gait assessment using an instrumented insole system during the Timed Up and Go Test. The device is used solely for data collection and does not provide therapeutic intervention. | Other | TKA Patients |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement
Time frame: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months
Improvement in patient-reported symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a validated patient-reported outcome measure consisting of 24 items assessing pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale (0-4), resulting in a total score ranging from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation, and lower scores indicate better clinical status. Postoperative improvement is defined as a decrease of ≥15 points in the WOMAC total score compared with the preoperative baseline, corresponding to the minimal clinically important difference (MCID). Participants will be classified as "improved" or "not improved" based on this criterion (binary outcome).
1 secondary outcome
Timed Up and Go Test (TUGT) Improvement
Time frame: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months
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 26 Jan 2026.
- Background: PubMed 37883429Srivastava AK; Surgical Management of Osteoarthritis of the Knee Work Group, Staff of the American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee. J Am Acad Orthop Surg. 2023 Dec 15;31(24):1211-1220. doi: 10.5435/JAAOS-D-23-00338. Epub 2023 Oct 24.
- Background: PubMed 31888943Small SR, Bullock GS, Khalid S, Barker K, Trivella M, Price AJ. Current clinical utilisation of wearable motion sensors for the assessment of outcome following knee arthroplasty: a scoping review. BMJ Open. 2019 Dec 29;9(12):e033832. doi: 10.1136/bmjopen-2019-033832.
- Background: PubMed 33511585Ferreira AM, Salim R, Fogagnolo F, de Oliveira LFL, Riberto M, Kfuri M. The Value of a Standardized Knee Functional Assessment in Predicting the Outcomes of Total Knee Arthroplasty. J Knee Surg. 2022 Aug;35(10):1126-1131. doi: 10.1055/s-0040-1722321. Epub 2021 Jan 28.
- Background: PubMed 36193431Boekesteijn R, Smolders J, Busch V, Keijsers N, Geurts A, Smulders K. Objective monitoring of functional recovery after total knee and hip arthroplasty using sensor-derived gait measures. PeerJ. 2022 Sep 28;10:e14054. doi: 10.7717/peerj.14054. eCollection 2022.
- Background: PubMed 33167444Hsieh CY, Huang HY, Liu KC, Chen KH, Hsu SJ, Chan CT. Subtask Segmentation of Timed Up and Go Test for Mobility Assessment of Perioperative Total Knee Arthroplasty. Sensors (Basel). 2020 Nov 5;20(21):6302. doi: 10.3390/s20216302.
- Background: PubMed 12880577Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x.
- Background: PubMed 29128879Tolk JJ, Janssen RPA, Prinsen CAC, Latijnhouwers DAJM, van der Steen MC, Bierma-Zeinstra SMA, Reijman M. The OARSI core set of performance-based measures for knee osteoarthritis is reliable but not valid and responsive. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2898-2909. doi: 10.1007/s00167-017-4789-y. Epub 2017 Nov 11.
- Background: PubMed 32730319Wilfong JM, Badley EM, Power JD, Gandhi R, Rampersaud YR, Perruccio AV. Discordance between self-reported and performance-based function among knee osteoarthritis surgical patients: Variations by sex and obesity. PLoS One. 2020 Jul 30;15(7):e0236865. doi: 10.1371/journal.pone.0236865. eCollection 2020.
- Background: PubMed 28471509Cooper NA, Rakel BA, Zimmerman B, Tonelli SM, Herr KA, Clark CR, Noiseux NO, Callaghan JJ, Sluka KA. Predictors of multidimensional functional outcomes after total knee arthroplasty. J Orthop Res. 2017 Dec;35(12):2790-2798. doi: 10.1002/jor.23596. Epub 2017 May 23.
- Background: PubMed 33123659Young-Shand KL, Dunbar MJ, Astephen Wilson JL. Individual Gait Features Are Associated with Clinical Improvement After Total Knee Arthroplasty. JB JS Open Access. 2020 Apr 6;5(2):e0038. doi: 10.2106/JBJS.OA.19.00038. eCollection 2020 Apr-Jun.
- Background: PubMed 33997202Batailler C, Lording T, De Massari D, Witvoet-Braam S, Bini S, Lustig S. Predictive Models for Clinical Outcomes in Total Knee Arthroplasty: A Systematic Analysis. Arthroplast Today. 2021 Apr 24;9:1-15. doi: 10.1016/j.artd.2021.03.013. eCollection 2021 Jun.
- Background: PubMed 35816307Olsen U, Lindberg MF, Rose C, Denison E, Gay C, Aamodt A, Brox JI, Skare O, Furnes O, Lee K, Lerdal A. Factors Correlated With Physical Function 1 Year After Total Knee Arthroplasty in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Jul 1;5(7):e2219636. doi: 10.1001/jamanetworkopen.2022.19636.
- 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.
Na Young Kim, MD, PhD principal investigator
Severance Hospital
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 and Total Knee Arthroplasty, 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 4 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 26 Jan 2026. 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?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement (time frame: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months). 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 NCT07367789, which also lists 21 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 26 Jan 2026.