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Clinical application and safety of a computer-aided surgical navigation system (KNEE 3): a multi-center, randomized, open, parallel controlled clinical trail

Clinical application and safety of a computer-aided surgical navigation system (KNEE 3): a multi-center, randomized, open, parallel controlled clinical trail

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043754
Enrollment
Unknown
Registered
2021-02-27
Start date
2021-03-15
Completion date
Unknown
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

conventional total knee arthroplasty (A):control
Knee3 navigation-assisted total knee arthroplasty (B):computer-assisted osteotomy

Sponsors

Chinese PLA General Hospital, The First Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18~80, gender unlimited; 2) The patient was diagnosed with knee osteoarthritis that failed to be treated conservatively; 3) Patients who need the first unilateral total knee replacement as assessed by the investigator; 4) Subjects fully understand the benefits and risks of this test, and are willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Body mass index (BMI)>35kg/m^2 2) Patients with heart, lung and other important organ failure; 3) Abnormal liver and kidney function 4) Patients with diabetes and poor blood level control are at risk of infection according to the study; 5) Concomitant consciousness disorder or mental illness; 6) Have a history of open knee surgery; 7) Neuromuscular dysfunction affecting the lower limbs; 8) Patients with severe coagulation dysfunction; 9) Complicated with serious internal and surgical diseases or weak constitution, unable to tolerate surgery; 10) Severe unstable and ligament-preserved TKA cannot be cured;There is no cure; 11) Active infectious foci (systemic or local lesions); 12) Severe osteoporotic and metabolic radiation swelling around the knee joint; 13) Family planning, nursing and pregnant women throughout the clinical study period; 14) Participated in other clinical trials within 3 months; 15) The investigator considered that other reasons were not suitable for participants

Design outcomes

Primary

MeasureTime frame
Angle of femoral component in sagittal plane;Angle of tibial component in sagittal plane;Coronal plane femoral component Angle;Coronal plane tibial component Angle;Hip - knee - ankle Angle;

Secondary

MeasureTime frame
KSS score;WOMAC score;range of motion of the knee;Soft tissue balance parameters;Iatrogenic bone and soft tissue trauma;

Countries

China

Contacts

Public ContactJiying Chen

Chinese PLA General Hospital, The First Medical Center

jiying_chen301@163.com+86 13901078832

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026