OsteoarthritisNCT07003035
A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
An observational study of Osteoarthritis, run by YujiakuoTHU at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: This study will recruit adult patients aged 50-80 years who are undergoing total knee arthroplasty for end-stage knee osteoarthritis or related conditions. Participants will be selected from multiple hospital centers to ensure a diverse patient population.
Who may be able to join
- Patients aged 50-80 years.
- Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
- Willing and able to provide informed consent.
Who cannot join
- History of prior knee surgery or knee replacement.
- Severe knee deformity (valgus >20° or varus >15°) or instability.
- Severe contracture (>25° flexion contracture).
- Undergoing total knee revision surgery.
- Rheumatoid arthritis diagnosis.
- BMI >35.
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- Neuromuscular disorders affecting knee stability or gait.
- Pregnancy or lactation.
- Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
- Active or recent severe infections or malignancy.
- History of drug or alcohol abuse in the past six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: A Multi-Center Prospective Cohort Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.
Read the detailed description
This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized TKA system.
This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| Cohort 1 | A total of 80 participants will be enrolled, with 40 receiving personalized total knee arthroplasty and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
The Knee Society Score is a standardized assessment tool to evaluate pain, range of motion, and functional ability following total knee arthroplasty. It includes two sub-scores: a clinical knee score and a functional score.
Each sub-score ranges from 0 to 100, with higher scores indicating better outcomes.
Measured: At baseline, 6 months, and 12 months post-surgery
Secondary outcomes (7)
Pain Severity - Visual Analog Scale (VAS)
Pain severity will be measured using the VAS, a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate worse pain.
Measured: At baseline, 6 months, and 12 months post-surgery.
Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain will also be assessed using the WOMAC Pain Subscale, part of the validated WOMAC Index for knee osteoarthritis.
Each item is scored from 0 to 4, and the subscale total ranges from 0 (no pain) to 20 (maximum pain).
Higher scores indicate worse pain.
Measured: At baseline, 6 months, and 12 months post-surgery
Functional Improvement - SF-36 Health Survey
Physical function will be assessed using the 36-Item Short Form Health Survey (SF-36). The Physical Functioning domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: At baseline, 6 months, and 12 months post-surgery.
Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a validated tool assessing knee function across five domains. Each domain score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.
Measured: At baseline, 6 months, and 12 months post-surgery
Functional Improvement - Gait Analysis
Gait performance will be evaluated using temporospatial parameters such as gait speed (m/s), step length (cm), and cadence (steps/min), measured using standardized motion capture or pressure-sensitive walkways.
Measured: At baseline, 6 months, and 12 months post-surgery
Prosthesis Positioning and Alignment
Radiographic evaluation will assess implant positioning and limb alignment.
Measured: At baseline and 12 months post-surgery.
Surgical Complication Rate
The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.
Measured: At 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YujiakuoTHU
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital, Beijing Chao Yang Hospital
- Responsible party
- Sponsor-investigator, YujiakuoTHU, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003035
- Sponsor's protocol ID
- 23705-4-02
- Status last verified
- May 2025
- First submitted
- 18 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Cohort Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
- ClinicalTrials.gov ID
- NCT07003035
- Acronym / sponsor ID
- 23705-4-02
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- YujiakuoTHUUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital, Beijing Chao Yang Hospital
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 2025 (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 purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.
Detailed description
This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized TKA system.
This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –A total of 80 participants will be enrolled, with 40 receiving personalized total knee arthroplasty and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will recruit adult patients aged 50-80 years who are undergoing total knee arthroplasty for end-stage knee osteoarthritis or related conditions. Participants will be selected from multiple hospital centers to ensure a diverse patient population.
Key inclusion criteria (3 listed)
- Patients aged 50-80 years.
- Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
- Willing and able to provide informed consent.
Key exclusion criteria (11 listed)
- History of prior knee surgery or knee replacement.
- Severe knee deformity (valgus >20° or varus >15°) or instability.
- Severe contracture (>25° flexion contracture).
- Undergoing total knee revision surgery.
- Rheumatoid arthritis diagnosis.
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
Knee Society Score (KSS)
Time frame: At baseline, 6 months, and 12 months post-surgery
The Knee Society Score is a standardized assessment tool to evaluate pain, range of motion, and functional ability following total knee arthroplasty. It includes two sub-scores: a clinical knee score and a functional score. Each sub-score ranges from 0 to 100, with higher scores indicating better outcomes.
7 secondary outcomes
Pain Severity - Visual Analog Scale (VAS)
Time frame: At baseline, 6 months, and 12 months post-surgery.
Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: At baseline, 6 months, and 12 months post-surgery
Functional Improvement - SF-36 Health Survey
Time frame: At baseline, 6 months, and 12 months post-surgery.
Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline, 6 months, and 12 months post-surgery
Functional Improvement - Gait Analysis
Time frame: At baseline, 6 months, and 12 months post-surgery
Prosthesis Positioning and Alignment
Time frame: At baseline and 12 months post-surgery.
Surgical Complication Rate
Time frame: At 12 months post-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 4 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by YujiakuoTHU at 1 site in China.
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 11 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: opening soon, as of the sponsor's last update on 4 Jun 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 China. 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?
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 Society Score (KSS) (time frame: At baseline, 6 months, and 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.