Knee OsteoarthritisAI-TKANCT06634654
An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine
A study testing Total Knee Arthroplasty, Multifaceted diagnostic assessments and Follow-ups in people with Knee Osteoarthritis, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
Goal: The goal of this interventional study is to understand how multimodal preoperative data can predict outcomes after Total Knee Arthroplasty (TKA) and improve personalized medicine practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty, Multifaceted diagnostic assessments and Follow-ups
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2024to Dec 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic, end-stage knee osteoarthritis
- Ligaments functionally intact
- Age: older than18 years old
Who cannot join
- Neurological or other conditions affecting patients ability to join walking trials
- Inflammatory or infectious arthritis
- Previous articular fracture or knee surgery (excluding knee arthroscopy and meniscal surgery)
- Active tumors or pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
Umile Giuseppe Longo, MD, MSc, PhD
About this study
Goal: The goal of this interventional study is to understand how multimodal preoperative data can predict outcomes after Total Knee Arthroplasty (TKA) and improve personalized medicine practices.
Participant Population: The study will enroll 197 patients suffering from symptomatic, end-stage knee osteoarthritis, who are above 18 years old and have functionally intact ligaments.
Read more
Main Questions:
- Can multimodal preoperative data, genetic predisposition, and psycho-behavioral characteristics predict outcomes after TKA?
- Can AI models effectively use this data to customize prostheses and surgical interventions, and predict patient outcomes? Comparison Group Information (If applicable): Not specified in the provided details.
Participant Tasks:
- Undergo TKA as per the normal clinical routine.
- Participate in pre- and post-surgical follow-ups including:
- Clinical-functional assessments.
- Administration of clinical scores.
- Collection of biological samples.
- Biomechanical analysis using a stereophotogrammetric system.
- Provide data for the comprehensive multimodal indexed database.
Read the detailed description
Osteoarthritis is one of the most common causes of knee disorders, leading to pain, reduced mobility, and a decline in quality of life. Total knee arthroplasty (TKA) is one of the most established treatments for end-stage osteoarthritis. Despite advancements in surgical techniques, patient dissatisfaction remains high. After surgery, patients often experience swelling, pain, and difficulty with daily activities. Revision surgery is a major challenge, with aseptic loosening occurring in 15-20% of cases. Given the high disability rates and healthcare costs associated with TKA, optimizing patient care is crucial.
Artificial intelligence (AI) offers the potential to identify new care profiles. For the first time, AI can integrate multimodal datasets. This approach could lead to personalized treatment for knee osteoarthritis patients, in line with precision medicine principles. This study takes a multidisciplinary approach to better understand the causes of failure and dissatisfaction following TKA.
The primary aim of this study is is to create a multimodal database. This database will include structural, genetic, biomechanical, clinical, psychological, biological, stress-related, inflammatory, and demographic data. Using AI, the study aims to build predictive models for post-TKA outcomes. Insights from this research could improve patient management and lead to new therapeutic approaches.
Patients suffering from knee osteoarthritis at Fondazione Policlinico Universitario Campus Bio-Medico will be enrolled in this study if they meet the inclusion/exclusion criteria described above.
There are no risks for the patients recruited in the study. The total duration of the study is 5 years. The enrolment of patients will start on the 01/10/2024 and will last 12 months for each patient.
The Italian Ministry of Health and the Fondazione Policlinico Universitario Campus Bio-Medico supported this study.
The PI and also the main contact of this study is professor Umile Giuseppe Longo.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total Knee Arthroplasty, Multifaceted diagnostic assessments, Follow-ups, Genetic screening
- Keywords
- Artificial Intelligence, Total Knee Arthroplasty, Biomechanics, Orthopaedic surgery, Alarmins, Oxidative Stress, Cytokine, Knee Inflammation, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Total Knee Arthroplasty is performed using conventional surgical techniques.
Multifaceted diagnostic assessmentsDiagnostic test
Multifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations.
Follow-upsBehavioural
Postoperative follow-up includes behavioral interventions, such as lifestyle counseling and rehabilitation programs, tailored based on AI-driven insights into individual patient recovery profiles.
Genetic screeningGenetic
Genetic screening and analysis, including whole exome sequencing, are conducted to identify genetic markers that might influence the outcomes of knee arthroplasty. This data is utilized within AI models to predict patient-specific surgical outcomes and recovery processes.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo total total knee arthroplasty | Experimental | The study population comprises 197 patients who require Total Knee Arthroplasty (TKA) due to symptomatic, end-stage knee osteoarthritis. Eligible participants are adults over the age of 18 years with functionally intact ligaments. Exclusion criteria include individuals with neurological or other conditions that affect their ability to participate in walking trials, those with inflammatory or infectious arthritis, previous significant knee surgeries such as articular fractures (excluding knee arthroscopy and meniscal surgery), and those with active tumors or who are pregnant. This population selection is aimed at assessing the efficacy of AI-integrated interventions in improving surgical outcomes and postoperative recovery in a homogeneous group affected by severe knee degeneration. Receives: Procedure: Total Knee Arthroplasty; Diagnostic Test: Multifaceted diagnostic assessments; Behavioral: Follow-ups; Genetic: Genetic screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Knee Society Score (KSS) at 12 months
The KSS is a clinician-based assessment tool that evaluates both knee function and functional activities after knee replacement surgery.
Minimum/Maximum Values: The KSS is divided into two parts: knee score and function score, with a combined score ranging from 0 to 100. Higher scores indicate a better outcome in terms of knee function and overall knee health.
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change From Baseline in Oxford Knee Score (OKS) at 12 months
The OKS is used to assess pain and function in individuals undergoing knee surgery or experiencing knee osteoarthritis, focusing on the patient\'s perspective.
Minimum/Maximum Values: The OKS ranges from 0 to 48. Higher scores represent a better outcome, with less pain and better joint function.
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months
The KOOS is widely used to evaluate short- and long-term patient-reported outcomes following knee injury or surgery.
Minimum/Maximum Values: The KOOS assesses five dimensions: pain, symptoms, function in daily living, function in sports/recreation, and knee-related quality of life. Each subscale ranges from 0 to 100. Higher scores reflect a better outcome, indicating fewer symptoms and better function.
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change From Baseline in Forgotten Joint Score Short Form (FJS-12) at 12 months
The FJS-12 measures how much a patient is aware of their joint in daily activities, particularly after joint replacement surgery, with higher scores reflecting greater joint integration.
Minimum/Maximum Values: The FJS-12 ranges from 0 to 100. High scores indicate good outcomes
Measured: Before surgery (Baseline) and at 12 months postoperatively
Secondary outcomes (14)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months
The WOMAC is commonly used to evaluate pain, stiffness, and physical function in patients with osteoarthritis, particularly in the knee and hip.
Minimum/Maximum Values: The WOMAC ranges from 0 to 96. High scores indicate best functional status level
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in knee range of motion (ROM) at 12 months
Knee joint ROM (measured in degree) will be assessed during gait using a 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in ground reaction forces at 12 months
Ground reaction forces (measured in Newtons) during gait will be measured using force platforms synchronized with the 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in center of pressure (CoP) at 12 months
The CoP (measured in meters) will be measured during gait using force platforms synchronized with the 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in walking speed at 12 months
Walking speed (measured in meters per seconds) will be extracted using force platforms synchronized with the 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in cadence at 12 months
Cadence (measured in steps per minute) will be assessed during gait using force platforms synchronized with the 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in Step and Stride Length at 12 months
Step and Stride length (measured in meters) will be evaluate during gait using force platforms synchronized with the 3D motion capture system
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in osteoarthritis (OA) severity based on the Kellgren-Lawrence score at 12 months
The severity of OA will be assessed using the Kellgren-Lawrence global radiographic score. Changes in OA severity will be graded on a scale from 0 to 4, with 0 indicating no OA and 4 indicating severe OA
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in joint alignment at 12 months
The changes in joint alignment (measured in degrees) will be evaluated using X-rays to determine any shifts in anatomical alignment post-surgery
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in lateral distal femoral angle at 12 months
The lateral distal femoral angle (measured in degrees) will be measured using X-rays to assess the alignment of the femur
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in medial proximal tibial angle at 12 months
The medial proximal tibial angle will be measured to evaluate tibial alignment. X-rays will be used to assess changes in medial proximal tibial angle (measured in degrees)
Measured: Baseline (before surgery) and 12 months postoperatively
Change from baseline in joint line convergence angle at 12 months
The joint line convergence angle (measured in degrees) will be measured using X-rays to evaluate the alignment of the knee joint
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in tibial slope at 12 months
The tibial slope (measured in degrees) will be assessed using X-rays to measure the posterior inclination of the tibial plateau
Measured: Before surgery (Baseline) and at 12 months postoperatively
Change From Baseline in the fecal microbiota profiles at 12 months
Measured: Before surgery and at 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start14 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2029 (estimated)
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 Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umile Giuseppe Longo, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634654
- Sponsor's protocol ID
- 179.24 CET2 cbm
- Other IDs
- PNRR-MCNT2-2023-12378237
- Acronym
- AI-TKA
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The ownership of the data is of the promoter and shared with the investigators and will be managed according to the agreements between the participating institutions and with the researchers. Data Property belongs to Fondazione Policlinico Universitario Campus Bio-Medico. The personnel involved in this study will have access to all data. In agreement with the ICH-GCP, the principal investigator of the study agrees to produce a report on the study, share all the data collected as described in the Protocol, and ensure that the data are reported responsibly and consistently. The transmission or dissemination of data through scientific publications and/or presentations in congresses, conferences, seminars, and participation in multicenter studies will take place exclusively following a purely statistical processing of the same, or in any case, in an anonymous form.
Publications
Spallone G, Mancini L, Carnevale A, Campi S, Schena E, D'Hooghe P, Hirschmann MT, Papalia R, Longo UG. Joint modeling and marker set selection significantly influence functional biomechanics in end-stage knee osteoarthritis: evidence from the sit-to-stand task. Front Bioeng Biotechnol. 2025 Oct 13;13:1677244. doi: 10.3389/fbioe.2025.1677244. eCollection 2025.
PubMed 41158195
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine
- ClinicalTrials.gov ID
- NCT06634654
- Acronym / sponsor ID
- AI-TKA / 179.24 CET2 cbm
- Conditions
- Knee Osteoarthritis
- Keywords
- Artificial Intelligence, Total Knee Arthroplasty, Biomechanics, Orthopaedic surgery, Alarmins, Oxidative Stress, Cytokine, Knee Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Oct 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.
Goal: The goal of this interventional study is to understand how multimodal preoperative data can predict outcomes after Total Knee Arthroplasty (TKA) and improve personalized medicine practices.
Participant Population: The study will enroll 197 patients suffering from symptomatic, end-stage knee osteoarthritis, who are above 18 years old and have functionally intact ligaments.
Main Questions:
- Can multimodal preoperative data, genetic predisposition, and psycho-behavioral characteristics predict outcomes after TKA?
- Can AI models effectively use this data to customize prostheses and surgical interventions, and predict patient outcomes? Comparison Group Information (If applicable): Not specified in the provided details.
Participant Tasks:
- Undergo TKA as per the normal clinical routine.
- Participate in pre- and post-surgical follow-ups including:
- Clinical-functional assessments.
- Administration of clinical scores.
- Collection of biological samples.
- Biomechanical analysis using a stereophotogrammetric system.
- Provide data for the comprehensive multimodal indexed database.
Detailed description
Osteoarthritis is one of the most common causes of knee disorders, leading to pain, reduced mobility, and a decline in quality of life. Total knee arthroplasty (TKA) is one of the most established treatments for end-stage osteoarthritis. Despite advancements in surgical techniques, patient dissatisfaction remains high. After surgery, patients often experience swelling, pain, and difficulty with daily activities. Revision surgery is a major challenge, with aseptic loosening occurring in 15-20% of cases. Given the high disability rates and healthcare costs associated with TKA, optimizing patient care is crucial.
Artificial intelligence (AI) offers the potential to identify new care profiles. For the first time, AI can integrate multimodal datasets. This approach could lead to personalized treatment for knee osteoarthritis patients, in line with precision medicine principles. This study takes a multidisciplinary approach to better understand the causes of failure and dissatisfaction following TKA.
The primary aim of this study is is to create a multimodal database. This database will include structural, genetic, biomechanical, clinical, psychological, biological, stress-related, inflammatory, and demographic data. Using AI, the study aims to build predictive models for post-TKA outcomes. Insights from this research could improve patient management and lead to new therapeutic approaches.
Patients suffering from knee osteoarthritis at Fondazione Policlinico Universitario Campus Bio-Medico will be enrolled in this study if they meet the inclusion/exclusion criteria described above.
There are no risks for the patients recruited in the study. The total duration of the study is 5 years. The enrolment of patients will start on the 01/10/2024 and will last 12 months for each patient.
The Italian Ministry of Health and the Fondazione Policlinico Universitario Campus Bio-Medico supported this study.
The PI and also the main contact of this study is professor Umile Giuseppe Longo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo total total knee arthroplasty | Experimental | Procedure: Total Knee Arthroplasty, Diagnostic Test: Multifaceted diagnostic assessments, Behavioral: Follow-ups, Genetic: Genetic screeningThe study population comprises 197 patients who require Total Knee Arthroplasty (TKA) due to symptomatic, end-stage knee osteoarthritis. Eligible participants are adults over the age of 18 years with functionally intact ligaments. Exclusion criteria include individuals with neurological or other conditions that affect their ability to participate in walking trials, those with inflammatory or infectious arthritis, previous significant knee surgeries such as articular fractures (excluding knee arthroscopy and meniscal surgery), and those with active tumors or who are pregnant. This population selection is aimed at assessing the efficacy of AI-integrated interventions in improving surgical outcomes and postoperative recovery in a homogeneous group affected by severe knee degeneration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic, end-stage knee osteoarthritis
- Ligaments functionally intact
- Age: older than18 years old
Key exclusion criteria (4 listed)
- Neurological or other conditions affecting patients ability to join walking trials
- Inflammatory or infectious arthritis
- Previous articular fracture or knee surgery (excluding knee arthroscopy and meniscal surgery)
- Active tumors or pregnancy.
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 ArthroplastyTotal Knee Arthroplasty is performed using conventional surgical techniques. | Procedure or surgery | Patients who undergo total total knee arthroplasty |
| Multifaceted diagnostic assessmentsMultifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations. | Diagnostic test | Patients who undergo total total knee arthroplasty |
| Follow-upsPostoperative follow-up includes behavioral interventions, such as lifestyle counseling and rehabilitation programs, tailored based on AI-driven insights into individual patient recovery profiles. | Behavioural | Patients who undergo total total knee arthroplasty |
| Genetic screeningGenetic screening and analysis, including whole exome sequencing, are conducted to identify genetic markers that might influence the outcomes of knee arthroplasty. This data is utilized within AI models to predict patient-specific surgical outcomes and recovery processes. | Genetic | Patients who undergo total total knee arthroplasty |
Primary outcome
Change From Baseline in Knee Society Score (KSS) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
The KSS is a clinician-based assessment tool that evaluates both knee function and functional activities after knee replacement surgery. Minimum/Maximum Values: The KSS is divided into two parts: knee score and function score, with a combined score ranging from 0 to 100. Higher scores indicate a better outcome in terms of knee function and overall knee health.
Change From Baseline in Oxford Knee Score (OKS) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
The OKS is used to assess pain and function in individuals undergoing knee surgery or experiencing knee osteoarthritis, focusing on the patient\'s perspective. Minimum/Maximum Values: The OKS ranges from 0 to 48. Higher scores represent a better outcome, with less pain and better joint function.
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
The KOOS is widely used to evaluate short- and long-term patient-reported outcomes following knee injury or surgery. Minimum/Maximum Values: The KOOS assesses five dimensions: pain, symptoms, function in daily living, function in sports/recreation, and knee-related quality of life. Each subscale ranges from 0 to 100. Higher scores reflect a better outcome, indicating fewer symptoms and better function.
Change From Baseline in Forgotten Joint Score Short Form (FJS-12) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
The FJS-12 measures how much a patient is aware of their joint in daily activities, particularly after joint replacement surgery, with higher scores reflecting greater joint integration. Minimum/Maximum Values: The FJS-12 ranges from 0 to 100. High scores indicate good outcomes
14 secondary outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in knee range of motion (ROM) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in ground reaction forces at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in center of pressure (CoP) at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in walking speed at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in cadence at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in Step and Stride Length at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in osteoarthritis (OA) severity based on the Kellgren-Lawrence score at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in joint alignment at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in lateral distal femoral angle at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in medial proximal tibial angle at 12 months
Time frame: Baseline (before surgery) and 12 months postoperatively
Change from baseline in joint line convergence angle at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change from baseline in tibial slope at 12 months
Time frame: Before surgery (Baseline) and at 12 months postoperatively
Change From Baseline in the fecal microbiota profiles at 12 months
Time frame: Before surgery and at 12 months postoperatively
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 4 Mar 2026.
- Derived from this study: PubMed 41158195Spallone G, Mancini L, Carnevale A, Campi S, Schena E, D'Hooghe P, Hirschmann MT, Papalia R, Longo UG. Joint modeling and marker set selection significantly influence functional biomechanics in end-stage knee osteoarthritis: evidence from the sit-to-stand task. Front Bioeng Biotechnol. 2025 Oct 13;13:1677244. doi: 10.3389/fbioe.2025.1677244. eCollection 2025.
- Individual participant dataSharing planned: Yes. The ownership of the data is of the promoter and shared with the investigators and will be managed according to the agreements between the participating institutions and with the researchers. Data Property belongs to Fondazione Policlinico Universitario Campus Bio-Medico. The personnel involved in this study will have access to all data. In agreement with the ICH-GCP, the principal investigator of the study agrees to produce a report on the study, share all the data collected as described in the Protocol, and ensure that the data are reported responsibly and consistently. The transmission or dissemination of data through scientific publications and/or presentations in congresses, conferences, seminars, and participation in multicenter studies will take place exclusively following a purely statistical processing of the same, or in any case, in an anonymous form.
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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?
A study testing Total Knee Arthroplasty, Multifaceted diagnostic assessments and Follow-ups in people with Knee Osteoarthritis, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
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 4 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 4 Mar 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 Italy. 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 Umile Giuseppe Longo, MD, MSc, PhD (+39 06225418816, g.longo@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Knee Society Score (KSS) at 12 months (time frame: Before surgery (Baseline) and at 12 months postoperatively). The study lists 4 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 NCT06634654, 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 4 Mar 2026.