Knee OsteoarthritisNCT04950348
Clinical Trials of Prosthesis and Surgery Guide System
A study testing Personalized TKA prosthesis and Zimmer NexGen prostheses in people with Knee Osteoarthritis, run by Peking University Third Hospital at 1 site in China.
Trial summary
1. The subject continues the research of Professor JiaKuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee replacement artificial joint prostheses and the verification of animal and human cadavers. Read more about this study
- Who is it for?
- Ages 51 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Personalized TKA prosthesis and Zimmer NexGen prostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Dec 2021
- 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 51 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
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- 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 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 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;
- There is 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 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);
- 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); (2) Subjects whose serum creatinine level exceeds 2.0 mg/dl (176.8 μmol/L); (3) Total white blood cell (WBC) count at screening <2500/μL, or platelet <100000/μL or neutrophil <1500/μL or hemoglobin <8.5 g/dL; (4) Within six months before the baseline, there is a history of alcohol or drug abuse or evidence of ongoing abuse.
- 16) The patient is mentally incapable or unable to understand the requirements for participating in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-kuo Yu, MD, 86-13331031448, yujiakuo@126.com
About this study
Official title: Preliminary Exploration of Clinical Trials of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
- The subject continues the research of Professor JiaKuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee replacement artificial joint prostheses and the verification of animal and human cadavers. It is planned to carry out the femoral condyle prosthesis of personalized total knee replacement prosthesis. Clinical trials are carried out on the body, tibial tray prosthesis and meniscus prosthesis; at the same time, in order to achieve personalized precision surgery, the clinical trial verification is carried out on the placement of personalized surgical guides that match the personalized artificial joints.
- In the clinical verification study, the research team will summarize the role of personalized artificial joints for total knee replacement and personalized implant surgical guides in the precise and minimally invasive treatment of knee joint diseases.
Read the detailed description
This study aims to evaluate the safety and effectiveness of the femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of the personalized total knee replacement system; to verify the clinical feasibility and safety of the personalized surgical guide, as a personalized total knee replacement The clinical application of the prosthesis and its guide lays the foundation, including:
2.1 Evaluate the advantages of personalized total knee replacement surgery in osteotomy methods, evaluate the impact of anatomical osteotomy methods on intraoperative and postoperative effects and early and long-term clinical effects.
2.2 By measuring the amount of osteotomy in personalized total knee replacement surgery, evaluate the impact of a smaller and reasonable amount of osteotomy on the patient's early and long-term clinical results.
2.3 Verify the clinical effect of personalized total knee replacement prosthesis, and provide the basis for its clinical promotion and application.
- Conditions
- Knee Osteoarthritis
- Being tested
- Personalized TKA prosthesis, Zimmer NexGen prostheses
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized TKA prosthesisDevice
TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
Zimmer NexGen prosthesesDevice
Commercial products used on a large scale
| Study group | Role | What they receive |
|---|---|---|
| 3D printed personalized TKA prosthesis | Experimental | Patients in the experimental group received 3D printed personalized TKA prosthesis treatment Receives: Device: Personalized TKA prosthesis |
| Zimmer NexGen TKA prostheses | Active comparator | Patients in the active comparator group received Zimmer NexGen TKA prostheses treatment Receives: Device: Zimmer NexGen prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days postoperatively
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.
Measured: 3months postoperatively
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.
Measured: 6 months postoperatively
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.
Measured: 12 months postoperatively
Secondary outcomes (2)
Osteotomy
The size of the osteotomy
Measured: during surgery
Operation time
Operation time
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 May 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jia-kuo Yu, Prof., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950348
- Sponsor's protocol ID
- M2020519
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 6 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 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Exploration of Clinical Trials of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04950348
- Acronym / sponsor ID
- M2020519
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Inner Mongolia People's Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 6 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.
- The subject continues the research of Professor JiaKuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee replacement artificial joint prostheses and the verification of animal and human cadavers. It is planned to carry out the femoral condyle prosthesis of personalized total knee replacement prosthesis. Clinical trials are carried out on the body, tibial tray prosthesis and meniscus prosthesis; at the same time, in order to achieve personalized precision surgery, the clinical trial verification is carried out on the placement of personalized surgical guides that match the personalized artificial joints.
- In the clinical verification study, the research team will summarize the role of personalized artificial joints for total knee replacement and personalized implant surgical guides in the precise and minimally invasive treatment of knee joint diseases.
Detailed description
This study aims to evaluate the safety and effectiveness of the femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of the personalized total knee replacement system; to verify the clinical feasibility and safety of the personalized surgical guide, as a personalized total knee replacement The clinical application of the prosthesis and its guide lays the foundation, including:
2.1 Evaluate the advantages of personalized total knee replacement surgery in osteotomy methods, evaluate the impact of anatomical osteotomy methods on intraoperative and postoperative effects and early and long-term clinical effects.
2.2 By measuring the amount of osteotomy in personalized total knee replacement surgery, evaluate the impact of a smaller and reasonable amount of osteotomy on the patient's early and long-term clinical results.
2.3 Verify the clinical effect of personalized total knee replacement prosthesis, and provide the basis for its clinical promotion and application.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed personalized TKA prosthesis | Experimental | Device: Personalized TKA prosthesisPatients in the experimental group received 3D printed personalized TKA prosthesis treatment |
| Zimmer NexGen TKA prostheses | Active comparator | Device: Zimmer NexGen prosthesesPatients in the active comparator group received Zimmer NexGen TKA prostheses treatment |
Who may qualify
- Ages
- 51 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| Personalized TKA prosthesisTKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy | Device | 3D printed personalized TKA prosthesis |
| Zimmer NexGen prosthesesCommercial products used on a large scale | Device | Zimmer NexGen TKA prostheses |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Osteotomy
Time frame: during surgery
Operation time
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Jia-kuo Yu, Prof. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized TKA prosthesis and Zimmer NexGen prostheses in people with Knee Osteoarthritis, run by Peking University Third Hospital 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 17 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 6 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu-zhen Yuan (18511440808, yuanfuzhen2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical axis of the lower limb and prosthesis position (time frame: 7 days 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?
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 6 Jul 2021.