Health TrialsbyHealthPanel

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

ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Attune Total Knee Implant

    Device

    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.

  • Persona Total Knee Implant

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Attune Implant GroupExperimental treatment 1 intervention
Group B: Persona Implant GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (preoperative CT) and immediate postoperative period (postoperative CT)

Secondary outcomes

1

Pain assessment using the Visual Analog Scale (VAS)

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.

Time frame
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
2

Functional assessment using the Forgotten Joint Scores (FJS) and Knee injury and Osteoarthritis Outcome Score, Junior (KOOS, JR)

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.

Time frame
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
3

Quality of life measured by the Short-Form-12 health survey

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.

Time frame
Baseline (preoperative), 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively
4

Complications : Documenting any intraoperative or postoperative complications, including infection, dislocation, and need for revision surgery

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.

Time frame
Intraoperative (day of surgery) and postoperative at 6 weeks, 3 months, 6 months, 12 months, and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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