New Robotic Knee Surgery: Does Implant Type Affect Alignment Accuracy? (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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, prospective, double-blinded, randomized controlled trial (RCT) conducted at the Department of Orthopaedics & Traumatology, The Duchess of Kent Children's Hospital (DKCH), Hong Kong. The study aims to evaluate the accuracy of postoperative knee alignment relative to preoperative planning when using two different commercially available total knee arthroplasty (TKA) implant systems (Attune and Persona) in conjunction with a novel CT-based robotic surgical system (KUNWU® Robotic Surgical System, Yuanhua Robotics, Perception & AI Technologies Limited, Hong Kong).
Randomization and Blinding Eligible participants will be randomized in a 1:1 ratio to receive either the Attune or Persona implant using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The study is double-blinded: participants and outcome assessors will be blinded to implant allocation. The operating surgeon cannot be blinded due to the inherent differences in implant instrumentation and design.
Surgical Procedure All surgeries will be performed by a single surgical team using the KUNWU® robotic system. Preoperative planning will be based on CT-derived 3D models of the patient's knee joint, allowing for individualized determination of implant size, positioning, and alignment targets. Intraoperatively, the robotic system provides real-time haptic feedback and bone resection guidance to execute the preoperative plan. The choice of implant (Attune or Persona) is the only variable; all other aspects of the surgical procedure, including approach, soft tissue balancing, and postoperative rehabilitation protocol, will be standardized across both groups.
Assessments and Follow-up Schedule Participants will undergo a series of clinical and radiological assessments at specified time points throughout the study.
Imaging Assessments:
Computed Tomography (CT) scans will be performed preoperatively and once postoperatively to assess knee alignment.
Standard X-rays will be taken preoperatively, and at 3 months, 6 months, 12 months, and 24 months postoperatively.
Clinical Assessments:
All clinical outcome assessments will be administered by a blinded assessor. Assessments will take place preoperatively, and at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively. The following validated instruments will be used:
Pain Assessment: Visual Analog Scale (VAS) for pain
Functional Assessment: Forgotten Joint Score (FJS) and Knee Injury and Osteoarthritis Outcome Score, Junior (KOOS, JR)
Quality of Life Assessment: Short-Form-12 (SF-12) health survey
Safety Monitoring:
All intraoperative and postoperative complications, including but not limited to infection, dislocation, and need for revision surgery, will be documented throughout the follow-up period. Length of hospital stay and cost-effectiveness data will also be collected.
Summary of Assessment Schedule:
In summary, CT scans are performed twice (preoperatively and postoperatively), while X-rays are performed at five time points (preoperatively, 3 months, 6 months, 12 months, and 24 months). Clinical outcome assessments using VAS, FJS, KOOS, JR, and SF-12 are conducted at six time points (preoperatively, 6 weeks, 3 months, 6 months, 12 months, and 24 months). Complications are monitored at all postoperative visits from 6 weeks through 24 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F
- Phone Number: 92646862
- Email: laucml@hku.hk
Study Contact Backup
- Name: Kejing Eunice Ms. Xiao, Master
- Phone Number: 54845721
- Email: eunice7@hku.hk
Study Locations
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-
Sandy Bay
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Hong Kong, Sandy Bay, Hong Kong, 999077
- Recruiting
- The Duchess of Kent Children's Hospital at Sandy Bay
-
Contact:
- Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F
- Phone Number: 92646862
- Email: laucml@hku.hk
-
Contact:
- Kejing Eunice Ms Xiao, Master
- Phone Number: 54845721
- Email: eunice@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knee Alignment from Preoperative Plan to Postoperative Outcome
Time Frame: Baseline (preoperative CT) and immediate postoperative period (postoperative CT)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment using the Visual Analog Scale (VAS)
Time Frame: Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
|
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 100-mm horizontal line ranging from 0 (no pain) to 100 (worst imaginable pain).
Participants will be asked to mark their current level of knee pain on the scale.
The VAS is a validated and widely used instrument for assessing pain in patients with knee osteoarthritis and following total knee replacement.
|
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)
Time Frame: Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
|
Functional outcomes will be assessed using two validated, patient-reported instruments.
The Forgotten Joint Score (FJS) evaluates the patient's ability to forget about their replaced joint during daily activities, with higher scores indicating better awareness and function.
The Knee Injury and Osteoarthritis Outcome Score, Junior (KOOS, JR) is a short-form, joint-specific tool that assesses pain, symptoms, and function related to knee osteoarthritis.
Both instruments will be administered to evaluate patient-reported functional recovery following total knee replacement.
|
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
Time Frame: Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
|
Health-related quality of life will be assessed using the Short-Form-12 (SF-12) Health Survey, a validated 12-item questionnaire that measures physical and mental health components.
The SF-12 provides a summary of overall well-being and is widely used in orthopedic outcomes research.
It consists of 12 questions covering eight domains of health, including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
|
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
Time Frame: Intraoperative (day of surgery) and postoperative at 6 weeks, 3 months, 6 months, 12 months, and 24 months
|
All intraoperative and postoperative complications will be documented throughout the study period.
Documented events will include, but are not limited to, infection (superficial or deep), wound dehiscence, periprosthetic fracture, dislocation or instability, implant loosening, neurovascular injury, deep vein thrombosis, pulmonary embolism, stiffness requiring manipulation under anesthesia, and need for revision surgery.
Adverse events will be graded for severity and assessed for their relationship to the surgical procedure or implant.
All serious adverse events will be reported to the HKU/HA HKW Institutional Review Board within 24 hours.
|
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.
Time Frame: Hospital discharge and 24 months postoperatively
|
Cost-effectiveness will be evaluated by analyzing direct medical costs associated with each implant group.
Cost parameters will include implant costs, operating theater time, anesthetic services, hospital length of stay, inpatient rehabilitation, outpatient follow-up visits, and any additional healthcare utilization related to complications or revision surgeries.
Total costs will be compared between the Attune and Persona groups to assess the economic impact of implant choice on overall healthcare resource utilization.
|
Hospital discharge and 24 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 25-413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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