- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963491
Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
A Prospective Cohort Clinical Trial Study of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The subject continues the research of Professor Jia-kuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee arthroplasty (TKA) prostheses and the verification of animal and human cadavers. It is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides.
In the clinical validation study, the research team will summarize the role of personalized TKA prostheses and personalized TKA cutting guides in the precise and minimally invasive treatment of knee osteoarthritis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fu-zhen Yuan
- Phone Number: 18511440808
- Email: yuanfuzhen2016@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease and other end-stage knee joint diseases, as well as the 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.
- The subject or guardian is willing and able to sign an informed consent form.
Exclusion Criteria:
- History of previous knee surgery.
- Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability;
- Severe flexion contracture deformity (flexion contracture> 25°);
- Perform total knee joint revision and replacement surgery;
- Rheumatoid arthritis;
- Body Mass Index (BMI) > 35.
- Patients with neuromuscular insufficiency (for example, paralysis, myolysis or muscle weakness) can lead to postoperative knee instability or abnormal gait;
- Pregnant or lactating women;
- Suffer from the underlying medical condition (including but not limited to metabolism, hematology, kidney, liver, lung, nerve, endocrine, heart, infection or gastrointestinal tract) that the researcher believes that the patient is at an unacceptable risk; Serious progressive or uncontrolled diseases that are not suitable for trials or put them at high risk, including any medical or psychiatric conditions that the investigator believes will prevent subjects 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.
- Suffer from a progressive infection or malignant disease, and be able to provide chest X-ray, computed tomography (CT scan) or MRI evidence within 12 weeks before screening, and be verified by a qualified physician.
- Active systemic infections (except colds) or any other infections that will recur regularly during the previous two weeks.
- There is a history of chronic or recurrent infectious diseases, or evidence of tuberculosis infection that was judged 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 malignant tumor, or history of malignant tumor of any organ system in the past 5 years (Bowen's disease, basal cell carcinoma, or actinic keratosis after treatment and no evidence of recurrence in the past 12 weeks Except for diseases; except for excised cervical carcinoma in situ or non-invasive malignant colon polyps).
- At the same time suffering from medical problems, 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 exceeding 2.0 mg/dl (176.8 μmol/L).
- Total white blood cell (WBC) count at screening <2500/μL, or platelet <100000/μL or neutrophil <1500/μL or hemoglobin <8.5 g/dL.
- In the six months before the baseline, there is 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D printed personalized TKA prosthesis
Design:Personalized TKA prosthesis Manufacture:3D
|
TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
|
Active Comparator: Zimmer NexGen TKA prostheses
Prosthesis has been widely used in clinic
|
Commercial products used on a large scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mechanical axis of the lower limb and prosthesis position
Time Frame: 7 days postoperatively
|
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
|
7 days postoperatively
|
Mechanical axis of the lower limb and prosthesis position
Time Frame: 3months postoperatively
|
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
|
3months postoperatively
|
Mechanical axis of the lower limb and prosthesis position
Time Frame: 6 months postoperatively
|
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
|
6 months postoperatively
|
Mechanical axis of the lower limb and prosthesis position
Time Frame: 12 months postoperatively
|
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
|
12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteotomy during TKA
Time Frame: during surgery
|
The size of the osteotomy
|
during surgery
|
Operation time
Time Frame: during surgery
|
operation time
|
during surgery
|
VAS score
Time Frame: 7 days postoperatively
|
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
|
7 days postoperatively
|
VAS score
Time Frame: 3months postoperatively
|
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
|
3months postoperatively
|
VAS score
Time Frame: 6 months postoperatively
|
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
|
6 months postoperatively
|
VAS score
Time Frame: 12 months postoperatively
|
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
|
12 months postoperatively
|
KSS score
Time Frame: 7 days postoperatively
|
knee society score, the scale is 0-200 and 0 is worse.
|
7 days postoperatively
|
KSS score
Time Frame: 3months postoperatively
|
knee society score, the scale is 0-200 and 0 is worse.
|
3months postoperatively
|
KSS score
Time Frame: 6 months postoperatively
|
knee society score, the scale is 0-200 and 0 is worse.
|
6 months postoperatively
|
KSS score
Time Frame: 12 months postoperatively
|
knee society score, the scale is 0-200 and 0 is worse.
|
12 months postoperatively
|
WOMAC score
Time Frame: 7 days postoperatively
|
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
|
7 days postoperatively
|
WOMAC score
Time Frame: 3months postoperatively
|
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
|
3months postoperatively
|
WOMAC score
Time Frame: 6 months postoperatively
|
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
|
6 months postoperatively
|
WOMAC score
Time Frame: 12 months postoperatively
|
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
|
12 months postoperatively
|
SF-36 score
Time Frame: 7 days postoperatively
|
short form 36 questionnaire, scale is 0-100 and 0 is worse.
|
7 days postoperatively
|
SF-36 score
Time Frame: 3months postoperatively
|
short form 36 questionnaire, scale is 0-100 and 0 is worse.
|
3months postoperatively
|
SF-36 score
Time Frame: 6 months postoperatively
|
short form 36 questionnaire, scale is 0-100 and 0 is worse.
|
6 months postoperatively
|
SF-36 score
Time Frame: 12 months postoperatively
|
short form 36 questionnaire, scale is 0-100 and 0 is worse.
|
12 months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jia-kuo Yu, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2020518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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