Arthroplasty, Replacement, KneeNCT04976400
Men and Women With Different Designs and Semi-individual Total Knee Replacement
A study testing semi-individualized total knee replacement treatment with a gender-specific design and Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA) in people with Arthroplasty, Replacement, Knee, run by Peking University Third Hospital.
Trial summary
This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- semi-individualized total knee replacement treatment with a gender-specific design and Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Various end-stage knee joint diseases such as degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease, as well as correction of deformities, reconstruction after failure of some knee joint prostheses, and other techniques that cannot be handled In the case of fractures, total knee prosthesis replacement is required.
- Age ≥50, ≤80 years old.
- Subjects or guardians are willing and able to sign informed consent.
Who cannot join
- History of previous knee surgery.
- Severe knee deformity (valgus greater than 15° or valgus greater than 20°) or knee instability;
- Severe flexion contracture deformity (flexion contracture> 25°);
- Undertake total knee joint revision and replacement surgery;
- Rheumatoid arthritis;
- Body Mass Index (BMI)> 35.
Show all 20Show fewer
- Patients with neuromuscular insufficiency (such as paralysis, myolysis, or muscle weakness) can lead to postoperative knee instability or abnormal gait;
- Pregnant or breastfeeding women;
- Suffer from the underlying medical condition that the researcher believes that the patient is at an unacceptable risk (including but not limited to metabolism, hematology, kidney, liver, lung, nerve, endocrine, heart, infection, or gastrointestinal tract);
- the current patient is not suitable Tests or severely progressive or uncontrolled diseases that put them at high risk, including any medical or psychiatric conditions that the investigator believes will prevent the subject from following the protocol or completing the study according to the protocol.
- Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C, or a corresponding medical history.
- Suffering from a progressive infection or malignant disease, can provide chest X-ray, computed tomography (CT scan) or MRI evidence within 12 weeks before screening, and it is verified by a qualified physician.
- Active systemic infections (except colds) or any other infections that will recur regularly during the previous two weeks.
- A history of chronic or recurrent infectious diseases, or evidence of tuberculosis infection that was determined to be positive at the time of screening.
- Subjects who have obtained positive or uncertain results can participate in the study if they have undergone a comprehensive tuberculosis examination (according to local practice/guidelines) within 12 weeks before baseline and finally confirmed that there is no evidence of active tuberculosis. If the presence of latent tuberculosis is confirmed, treatment must be initiated and maintained in accordance with local or national guidelines before the baseline.
- History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years (except for Bowen's disease, basal cell carcinoma, or actinic keratosis that has been treated and has no evidence of recurrence in the past 12 weeks ; Except for excised cervical carcinoma in situ or non-invasive malignant colon polyps).
- Suffer from medical problems at the same time, including but not limited to the following: Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥95mmHg), congestive heart failure (New York Heart Association status classification III or IV).
- Subjects with a serum creatinine level greater than 2.0 mg/dl (176.8 μmol/L). During screening, total white blood cell (WBC) count <2500/μL, or platelet <100000/μL or neutrophil <1500/μL or hemoglobin <8.5 g/dL.
- During the six months before the baseline, there was a history of alcohol or drug abuse or evidence of ongoing abuse.
- The patient is mentally incapable or unable to understand the requirements for participating in the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on Clinical Solutions of Artificial Joints for Men and Women With Different Designs and Semi-individual Total Knee Replacement：A Prospective Cohort Clinical Trial Study
This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including:
- Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method.
- To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy.
- Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.
Read the detailed description
Patients meeting the inclusion and exclusion criteria were divided into the experimental group and the control group according to the patient's wishes. Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. The control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- semi-individualized total knee replacement treatment with a gender-specific design, Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)
- Keywords
- Total knee replacement, gender
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-individualized total knee replacement treatment with a gender-specific designProcedure or surgery
Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.
Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)Procedure or surgery
Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Semi-individualized total knee arthroplasty Receives: Procedure: semi-individualized total knee replacement treatment with a gender-specific design |
| Control group | Active comparator | Zimmer standard prosthesis total knee replacement Receives: Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Measured: Before operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Measured: 5 days after operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Measured: 6 months after operation
lower limb alignment
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Measured: 12 months after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Measured: 5 days after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Measured: 6 months after operation
Knee prosthesis position
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Measured: 12 months after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Measured: 5 days after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Measured: 6 months after operation
Gait analysis
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Measured: 12 months after operation
Secondary outcomes (18)
Operation time
from cutting the skin to completing the suture of the incision
Measured: during surgery
The amount of bleeding
from cutting the skin to completing the suture of the incision
Measured: during surgery
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Measured: Before operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Measured: 5 days after operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Measured: 6 months after operation
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Measured: 12 months after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Measured: Before operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Measured: 5 days after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Measured: 6 months after operation
KSS score
knee society score, the scale is 0-200 and 0 is worse.
Measured: 12 months after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Measured: Before operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Measured: 5 days after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Measured: 6 months after operation
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Measured: 12 months after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Measured: Before operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Measured: 5 days after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Measured: 6 months after operation
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guizhou Orthopedics Hospital, Shenyang Orthopedic Hospital, West China Hospital, Xi'an Honghui Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Guizhou Medical University, Jining Medical University, Northern Jiangsu People's Hospital, Inner Mongolia People's Hospital, Shenzhen Pingle Orthopedic Hospital
- Responsible party
- Sponsor
- Investigators
- Jiakuo Yu, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976400
- Sponsor's protocol ID
- M2021299
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Clinical Solutions of Artificial Joints for Men and Women With Different Designs and Semi-individual Total Knee Replacement：A Prospective Cohort Clinical Trial Study
- ClinicalTrials.gov ID
- NCT04976400
- Acronym / sponsor ID
- M2021299
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Total knee replacement, gender
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Guizhou Orthopedics Hospital, Shenyang Orthopedic Hospital, West China Hospital, Xi'an Honghui Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Guizhou Medical University, Jining Medical University, Northern Jiangsu People's Hospital, Inner Mongolia People's Hospital, Shenzhen Pingle Orthopedic Hospital
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jul 2021 (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 study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including:
- Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method.
- To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy.
- Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.
Detailed description
Patients meeting the inclusion and exclusion criteria were divided into the experimental group and the control group according to the patient's wishes. Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. The control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: semi-individualized total knee replacement treatment with a gender-specific designSemi-individualized total knee arthroplasty |
| Control group | Active comparator | Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)Zimmer standard prosthesis total knee replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Various end-stage knee joint diseases such as degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease, as well as correction of deformities, reconstruction after failure of some knee joint prostheses, and other techniques that cannot be handled In the case of fractures, total knee prosthesis replacement is required.
- Age ≥50, ≤80 years old.
- Subjects or guardians are willing and able to sign informed consent.
Key exclusion criteria (20 listed)
- History of previous knee surgery.
- Severe knee deformity (valgus greater than 15° or valgus greater than 20°) or knee instability;
- Severe flexion contracture deformity (flexion contracture> 25°);
- Undertake total knee joint revision and replacement surgery;
- Rheumatoid arthritis;
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 |
|---|---|---|
| semi-individualized total knee replacement treatment with a gender-specific designPatients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. | Procedure or surgery | test group |
| Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA). | Procedure or surgery | Control group |
Primary outcome
lower limb alignment
Time frame: Before operation
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
lower limb alignment
Time frame: 5 days after operation
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
lower limb alignment
Time frame: 6 months after operation
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
lower limb alignment
Time frame: 12 months after operation
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Knee prosthesis position
Time frame: 5 days after operation
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Knee prosthesis position
Time frame: 6 months after operation
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Knee prosthesis position
Time frame: 12 months after operation
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
Gait analysis
Time frame: 5 days after operation
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Gait analysis
Time frame: 6 months after operation
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Gait analysis
Time frame: 12 months after operation
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
18 secondary outcomes
Operation time
Time frame: during surgery
The amount of bleeding
Time frame: during surgery
VAS score
Time frame: Before operation
VAS score
Time frame: 5 days after operation
VAS score
Time frame: 6 months after operation
VAS score
Time frame: 12 months after operation
KSS score
Time frame: Before operation
KSS score
Time frame: 5 days after operation
KSS score
Time frame: 6 months after operation
KSS score
Time frame: 12 months after operation
WOMAC score
Time frame: Before operation
WOMAC score
Time frame: 5 days after operation
WOMAC score
Time frame: 6 months after operation
WOMAC score
Time frame: 12 months after operation
SF-36 score
Time frame: Before operation
SF-36 score
Time frame: 5 days after operation
SF-36 score
Time frame: 6 months after operation
SF-36 score
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- 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. This study is not recruiting at the moment.
Jiakuo Yu, Doctor study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A study testing semi-individualized total knee replacement treatment with a gender-specific design and Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA) in people with Arthroplasty, Replacement, Knee, run by Peking University Third Hospital.
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 20 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: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiakuo Yu, Doctor (13331031448, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower limb alignment (time frame: Before operation). The study lists 10 primary outcomes in all. 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 26 Jul 2021.