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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Duchess of Kent Children's Hospital at Sandy Bay
RECRUITING
Hong Kong
Contact Information
Primary
Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F
laucml@hku.hk
92646862
Backup
Kejing Eunice Ms. Xiao, Master
eunice7@hku.hk
54845721
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Attune Implant Group
Participants in this arm will undergo total knee replacement surgery using the KUNWU® Robotic Surgical System with the Attune total knee implant. The surgical procedure, including preoperative CT-based planning and intraoperative robotic guidance, is standardized across both arms.
Experimental: Persona Implant Group
Participants in this arm will undergo total knee replacement surgery using the KUNWU® Robotic Surgical System with the Persona total knee implant. The surgical procedure, including preoperative CT-based planning and intraoperative robotic guidance, is standardized across both arms.
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov