Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized TKA prosthesis
Zimmer NexGen prostheses
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D printed personalized TKA prosthesis
Zimmer NexGen TKA prostheses
Arm Description
Design:Personalized TKA prosthesis Manufacture:3D
Prosthesis has been widely used in clinic
Outcomes
Primary Outcome Measures
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Mechanical axis of the lower limb and prosthesis position
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Secondary Outcome Measures
Osteotomy during TKA
The size of the osteotomy
Operation time
operation time
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
VAS score
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
KSS score
knee society score, the scale is 0-200 and 0 is worse.
KSS score
knee society score, the scale is 0-200 and 0 is worse.
KSS score
knee society score, the scale is 0-200 and 0 is worse.
KSS score
knee society score, the scale is 0-200 and 0 is worse.
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
WOMAC score
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
SF-36 score
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Full Information
NCT ID
NCT04963491
First Posted
June 17, 2021
Last Updated
July 14, 2021
Sponsor
Peking University Third Hospital
Collaborators
Inner Mongolia People's Hospital, Jining Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04963491
Brief Title
Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
Official Title
A Prospective Cohort Clinical Trial Study of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Inner Mongolia People's Hospital, Jining Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The subject 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D printed personalized TKA prosthesis
Arm Type
Experimental
Arm Description
Design:Personalized TKA prosthesis Manufacture:3D
Arm Title
Zimmer NexGen TKA prostheses
Arm Type
Active Comparator
Arm Description
Prosthesis has been widely used in clinic
Intervention Type
Device
Intervention Name(s)
Personalized TKA prosthesis
Intervention Description
TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
Intervention Type
Device
Intervention Name(s)
Zimmer NexGen prostheses
Intervention Description
Commercial products used on a large scale
Primary Outcome Measure Information:
Title
Mechanical axis of the lower limb and prosthesis position
Description
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time Frame
7 days postoperatively
Title
Mechanical axis of the lower limb and prosthesis position
Description
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time Frame
3months postoperatively
Title
Mechanical axis of the lower limb and prosthesis position
Description
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time Frame
6 months postoperatively
Title
Mechanical axis of the lower limb and prosthesis position
Description
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Osteotomy during TKA
Description
The size of the osteotomy
Time Frame
during surgery
Title
Operation time
Description
operation time
Time Frame
during surgery
Title
VAS score
Description
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time Frame
7 days postoperatively
Title
VAS score
Description
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time Frame
3months postoperatively
Title
VAS score
Description
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time Frame
6 months postoperatively
Title
VAS score
Description
Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.
Time Frame
12 months postoperatively
Title
KSS score
Description
knee society score, the scale is 0-200 and 0 is worse.
Time Frame
7 days postoperatively
Title
KSS score
Description
knee society score, the scale is 0-200 and 0 is worse.
Time Frame
3months postoperatively
Title
KSS score
Description
knee society score, the scale is 0-200 and 0 is worse.
Time Frame
6 months postoperatively
Title
KSS score
Description
knee society score, the scale is 0-200 and 0 is worse.
Time Frame
12 months postoperatively
Title
WOMAC score
Description
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time Frame
7 days postoperatively
Title
WOMAC score
Description
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time Frame
3months postoperatively
Title
WOMAC score
Description
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time Frame
6 months postoperatively
Title
WOMAC score
Description
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.
Time Frame
12 months postoperatively
Title
SF-36 score
Description
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time Frame
7 days postoperatively
Title
SF-36 score
Description
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time Frame
3months postoperatively
Title
SF-36 score
Description
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time Frame
6 months postoperatively
Title
SF-36 score
Description
short form 36 questionnaire, scale is 0-100 and 0 is worse.
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu-zhen Yuan
Phone
18511440808
Email
yuanfuzhen2016@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-kuo Yu
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
We'll reach out to this number within 24 hrs