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Clinical efficacy and safety of hip/knee replacement assisted by joint replacement navigation and positioning system for different prostheses

Clinical efficacy and safety of hip/knee replacement assisted by joint replacement navigation and positioning system for different prostheses

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081830
Enrollment
Unknown
Registered
2024-03-13
Start date
2024-03-30
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Osteoarthritis

Interventions

Robot-assisted total knee arthroplasty (rTKA):Patients undergoing TKA assisted by joint replacement navigation and positioning system
Traditional manual total knee arthroplasty (mTKA):Patients undergoing traditional manual total knee arthroplasty
Robot-assisted total hip arthroplasty (rTHA):Patients undergoing THA assisted by joint replacement navigation and positioning system
Traditional manual total hip arthroplasty (mTHA):Patients undergoing traditional manual total hip arthroplasty

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: TKA: (1) Age 18-80 years old, gender is not limited; (2) Patients diagnosed with knee osteoarthritis who did not respond to conservative treatment; (3) Patients who were assessed by the investigator to require unilateral first knee replacement surgery; (4) The subjects fully understand the benefits and risks of this experiment and are willing to participate and sign the informed consent. THA: (1) Over 18 years old, gender is not limited; (2) Patients should have indications for hip replacement surgery; (3) Patients voluntarily participate in clinical trials and are willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: TKA: (1) Patients with neuromuscular insufficiency (e.g., paralysis, myolysis) that will lead to postoperative dysfunction affecting lower limb function; (2) Patients with severe internal or surgical diseases or weak constitution who cannot tolerate surgery; (3) Charcot's arthritis; (4) There is an active infection in the body (systemic or local infectious lesions); (5) Serious osteoporosis, metabolic bone disease, radiation bone disease, and tumor around the knee joint; (6) Patients expected to have poor compliance; (7) Pregnant or lactating women, or patients who have family planning during the clinical study; (8) Other situations in which the investigator considers it inappropriate to participate in the study. THA: (1) Neuromuscular dysfunction, such as paralysis, myolysis, or abductor weakness which can lead to postoperative hip instability or gait abnormalities in patients; (2) Patients with a history of infection or suspected/confirmed infection in the hip joint or other parts of the body; (3) Known patient has a history of allergies to one or more implanted materials; (4) Patients with severe internal and surgical diseases or weak physical constitution who cannot tolerate surgery; (5) Patients with poor expected compliance; (6) Pregnant or lactating women, or patients who have family planning during the clinical study; (7) Other situations in which the investigator considers it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Hip-knee-ankle, HKA;Accuracy of acetabular cup implantation;

Secondary

MeasureTime frame
Accuracy of prosthesis implantation;KSS;WOMAC;Operation time;Anterior inclination and abduction angle degrees of acetabular cup implantation;The percentage of safe zones for accurate implantation of acetabular cups;Lower limb length accuracy;Harris hip score;

Countries

China

Contacts

Public ContactZongke Zhou

West China Hospital of Sichuan University

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

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