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CAPTAIN
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
Sponsor study identifier
interventional
100
1 country
1
Study Start
March 18, 2026
Actual (reported)Primary Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2026
Actual (reported)August 17, 2026
Actual (reported)August 20, 2026
Actual (reported)September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Knee Alignment from Preoperative Plan to Postoperative Outcome
Knee alignment will be assessed using the Hip-Knee-Ankle (HKA) angle and the Coronal Plane Alignment of the Knee (CPAK) classification. CPAK is derived from the Medial Proximal Tibial Angle (MPTA) and Lateral Distal Femoral Angle (LDFA), measured on CT scans. Postoperative alignment will be compared to the preoperative planned alignment to determine the accuracy of the robotic system in executing the surgical plan.
Baseline (preoperative CT) and immediate postoperative period (postoperative CT)
Pain assessment using the Visual Analog Scale (VAS)
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
Functional assessment using the Forgotten Joint Scores (FJS) and Knee injury and Osteoarthritis Outcome Score, Junior (KOOS, JR)
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
Quality of life measured by the Short-Form-12 health survey
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
Complications : Documenting any intraoperative or postoperative complications, including infection, dislocation, and need for revision surgery
Intraoperative (day of surgery) and postoperative at 6 weeks, 3 months, 6 months, 12 months, and 24 months
Cost-Effectiveness : Analysis of hospital costs, length of stay, and follow-up care.
Hospital discharge and 24 months postoperatively
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.
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.
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.
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.
The Duchess of Kent Children's Hospital at Sandy Bay
Hong Kong, Sandy Bay, 999077, Hong Kong
First Submitted
August 17, 2026
First Posted
August 20, 2026
Study Start
March 18, 2026
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
Individual participant data (IPD) will not be shared with other researchers due to institutional data protection policies and patient confidentiality requirements. Access to study data will be restricted to the principal investigator and designated study team members for the purposes of data analysis and publication. All data will be stored in a password-protected computer and retained for 5 years after study completion, after which it will be destroyed in accordance with the protocol.
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Source: ClinicalTrials.gov.
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