Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
Recruiting · NCT06856356 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
View the official record on ClinicalTrials.gov →Interventions studied
Conventional total knee arthroplastyRobot-assisted surgery
What this trial is about
The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Subjects voluntarily participate in the trial and sign the informed consent form;
- Aged 18 to 80 years old (inclusive), regardless of gender;
- Patients who need total knee replacement surgery;
- Those who can communicate well with the researchers and comply with the trial requirements.
Exclusion criteria
- Patients who are allergic to the drugs used in this trial or the implant materials;
- Patients with immature bone development;
- Patients with active infection;
- Patients with neuropathy of the knee joint;
- Patients with poor bone quality that is not conducive to prosthesis fixation;
- Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
- Patients with insufficient quadriceps muscle strength;
- Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
- Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
- Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
- Pregnant or lactating women;
- Patients with severe epilepsy or mental illness;
- Patients with alcohol dependence or drug addiction;
- Patients with severe coagulation disorders;
- Patients who have participated in or are participating in other clinical trials within one month of enrollment;
- Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.
Where it is running
1 location listed.
- the first affiliated hospital of USTC - Hefei, Anhui, China