Clinical Trials of Prosthesis and Surgery Guide System

NCT04950348 | Unknown

• 1 other identifier: M2020519
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (2)

• Osteotomy

  during surgery

• Operation time

  during surgery

Other Outcomes (3)

• KSS score

  7 days，3months， 6 months and 12 months postoperatively

• WOMAC score

  7 days，3months， 6 months and 12 months postoperatively

• SF-36 score

  7 days，3months， 6 months and 12 months postoperatively

Study Arms (2)

3D printed personalized TKA prosthesis

EXPERIMENTAL

Patients in the experimental group received 3D printed personalized TKA prosthesis treatment

Device: Personalized TKA prosthesis

Zimmer NexGen TKA prostheses

ACTIVE COMPARATOR

Patients in the active comparator group received Zimmer NexGen TKA prostheses treatment

Device: Zimmer NexGen prostheses

Interventions

Personalized TKA prosthesis DEVICE

TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy

3D printed personalized TKA prosthesis

Zimmer NexGen prostheses DEVICE

Commercial products used on a large scale

Zimmer NexGen TKA prostheses

Eligibility Criteria

• Age: 51 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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:

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Inner Mongolia People's Hospital: collaborator

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jia-kuo Yu, Prof.

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Fu-zhen Yuan

CONTACT

18511440808; yuanfuzhen2016@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)