New Robotic Knee Surgery: Does Implant Type Affect Alignment Accuracy?
Recruiting · NCT07777757 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Total knee replacement is a common surgery for patients with severe knee arthritis. To improve surgical accuracy, surgeons now use robotic systems to help plan and perform the procedure. A new robotic system called KUNWU® has been developed in Hong Kong. Unlike many other systems, it allows surgeons to choose from different brands of knee implants. This study is a randomized controlled trial. It will compare two different types of knee implants (Attune and Persona) used together with the KUNWU® robotic system. The main goal is to see how accurately the robotic system helps achieve the knee alignment that was planned before surgery. Alignment refers to the straightness and balance of the knee joint after the implant is placed. Participants will be adults with knee osteoarthritis who need a total knee replacement. They will be randomly assigned to receive either the Attune or Persona implant. All surgeries will be performed using the KUNWU® robotic system. Participants will have CT scans before and after surgery, and X-rays will be taken at regular follow-up visits over 24 months. Clinical assessments, including pain and function scores, will also be collected at various time points. The study will take place at the Department of Orthopaedics \& Traumatology, The Duchess of Kent Children's Hospital (DKCH). A total of 100 participants will be recruited. The study will run for approximately 36 months, with recruitment lasting 12 months and follow-up continuing for 24 months. The results will help determine whether the new robotic system can consistently achieve the planned alignment regardless of which implant is used. This information may help surgeons make better decisions about implant selection and robotic surgery in the future.
Who can take part
Inclusion criteria
- Adults aged 18 years and older.
- Diagnosis of symptomatic knee osteoarthritis requiring total knee replacement.
- Ability to give informed consent.
- Feasibility of using the two types of implants
Exclusion criteria
- \- Severe radiographic knee OA (Kellgren-Lawrence grade 4) or severe knee pain (VAS\>80mm/100 mm) that could not tolerate further conservative management
Where it is running
1 location listed.
- The Duchess of Kent Children's Hospital at Sandy Bay - Hong Kong, Sandy Bay, Hong Kong