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Tests treatment safety and results for Osteoarthritis, Knee
Official title Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06856356
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people 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.
You likely can't join if
- 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;
See the full eligibility criteria
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.