Clinical Trials of Prosthesis and Surgery Guide System

Preliminary Exploration of Clinical Trials of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

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. 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.
2. 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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Personalized TKA prosthesis; Device: Zimmer NexGen prostheses

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fu-zhen Yuan; Phone Number: 18511440808; Email: yuanfuzhen2016@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Institute of Sports Medicine, Peking University Third Hospital
      • Contact: Jia-kuo Yu, MD; Phone Number: 86-13331031448; Email: yujiakuo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Age ≥50, ≤80 years old.
3. The subject or guardian is willing and able to sign an informed consent form.

Exclusion Criteria:

1. History of previous knee surgery.
2. Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability;
3. Severe flexion contracture deformity (flexion contracture> 25°);
4. Perform total knee joint revision and replacement surgery;
5. Rheumatoid arthritis;
6. Body mass index (BMI)> 35.;
7. Patients with neuromuscular insufficiency (for example: paralysis, myolysis or muscle weakness) can lead to postoperative knee instability or abnormal gait;
8. Pregnant or lactating women;
9. 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;
10. Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C or corresponding medical history;
11. 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.
12. Active systemic infections (except colds) or any other infections that will recur regularly during the previous two weeks;
13. 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;
14. 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);
15. Suffer from medical problems at the same time, including but not limited to the following:

(1) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D printed personalized TKA prosthesis; Patients in the experimental group received 3D printed personalized TKA prosthesis treatment	Device: Personalized TKA prosthesis; TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
Active Comparator: Zimmer NexGen TKA prostheses; Patients in the active comparator group received Zimmer NexGen TKA prostheses treatment	Device: Zimmer NexGen prostheses; 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	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	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	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	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
Operation time	Operation time	during surgery
Osteotomy	The size of the osteotomy	during surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
KSS score	knee society score, the scale is 0-200 and 0 is worse.	7 days，3months， 6 months and 12 months postoperatively
WOMAC score	The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse.	7 days，3months， 6 months and 12 months postoperatively
SF-36 score	short form 36 questionnaire, scale is 0-100 and 0 is worse.	7 days，3months， 6 months and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Inner Mongolia People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: M2020519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No