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Knee OsteoarthritisNCT04963491

Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

A study testing Personalized TKA prosthesis and Zimmer NexGen prostheses in people with Knee Osteoarthritis, run by Peking University Third Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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
80 participants
Where
No sites listed yet
Study dates
1 Sep 2021to 31 Aug 2023
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 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.

Trial locations and contacts

No sites are listed yet.

Fu-zhen Yuan contact

18511440808

yuanfuzhen2016@163.com

About this study

Official title: A Prospective Cohort Clinical Trial Study of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

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.

Read the 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.

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 groups in NCT04963491
Study groupRoleWhat they receive
3D printed personalized TKA prosthesisExperimentalDesign：Personalized TKA prosthesis Manufacture：3D
Receives: Device: Personalized TKA prosthesis
Zimmer NexGen TKA prosthesesActive comparatorProsthesis has been widely used in clinic
Receives: Device: Zimmer NexGen prostheses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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

  4. 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 (18)

  1. Osteotomy during TKA

    The size of the osteotomy

    Measured: during surgery

  2. Operation time

    operation time

    Measured: during surgery

  3. VAS score

    Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.

    Measured: 7 days postoperatively

  4. VAS score

    Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.

    Measured: 3months postoperatively

  5. VAS score

    Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.

    Measured: 6 months postoperatively

  6. VAS score

    Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse.

    Measured: 12 months postoperatively

  7. KSS score

    knee society score, the scale is 0-200 and 0 is worse.

    Measured: 7 days postoperatively

  8. KSS score

    knee society score, the scale is 0-200 and 0 is worse.

    Measured: 3months postoperatively

  9. KSS score

    knee society score, the scale is 0-200 and 0 is worse.

    Measured: 6 months postoperatively

  10. KSS score

    knee society score, the scale is 0-200 and 0 is worse.

    Measured: 12 months postoperatively

  11. WOMAC score

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.

    Measured: 7 days postoperatively

  12. WOMAC score

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.

    Measured: 3months postoperatively

  13. WOMAC score

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.

    Measured: 6 months postoperatively

  14. WOMAC score

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.

    Measured: 12 months postoperatively

  15. SF-36 score

    short form 36 questionnaire, scale is 0-100 and 0 is worse.

    Measured: 7 days postoperatively

  16. SF-36 score

    short form 36 questionnaire, scale is 0-100 and 0 is worse.

    Measured: 3months postoperatively

  17. SF-36 score

    short form 36 questionnaire, scale is 0-100 and 0 is worse.

    Measured: 6 months postoperatively

  18. SF-36 score

    short form 36 questionnaire, scale is 0-100 and 0 is worse.

    Measured: 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963491
Sponsor's protocol ID
M2020518
Status last verified
Jun 2021
First submitted
17 Jun 2021
Last updated
15 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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 15 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 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?

On the ClinicalTrials.gov record for NCT04963491.

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 15 Jul 2021.

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