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RECRUITING
NCT07777757
NA

New Robotic Knee Surgery: Does Implant Type Affect Alignment Accuracy?

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

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 90-100 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.

Official title: Comparison of Postoperative Knee Alignment to Planned Alignment Using Two Implant Types and a Novel Robotic Platform in Total Knee Replacement - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-18

Completion Date

2028-12-31

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DEVICE

Attune Total Knee Implant

The Attune Total Knee Implant is a commercially available prosthetic knee system used in total knee replacement surgery. It is designed to provide stability and natural knee motion. In this study, it is used in conjunction with the KUNWU® Robotic Surgical System for implant positioning and bone resection guidance.

DEVICE

Persona Total Knee Implant

The Persona Total Knee Implant is a commercially available prosthetic knee system used in total knee replacement surgery. It is designed to provide personalized fit and function. In this study, it is used in conjunction with the KUNWU® Robotic Surgical System for implant positioning and bone resection guidance.

Locations (1)

The Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, Sandy Bay, Hong Kong