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

NCT07777757 | Recruiting

• 1 other identifier: UW 25-413
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthristis

Keywords

Total Knee Replacement; Robotic-Assisted Surgery; Knee Alignment; Knee Osteoarthritis

Outcome Measures

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.

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Attune Implant Group

EXPERIMENTAL

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.

Device: Attune Total Knee Implant

Persona Implant Group

EXPERIMENTAL

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.

Device: Persona Total Knee Implant

Interventions

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.

Attune Implant Group

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.

Persona Implant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Severe radiographic knee OA (Kellgren-Lawrence grade 4) or severe knee pain (VAS\>80mm/100 mm) that could not tolerate further conservative management

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, Sandy Bay, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Chun Man Lawrence Prof. Lau, MBChB, MRCSEd, FRCSEd(Orth), F

CONTACT

92646862; laucml@hku.hk

Kejing Eunice Ms. Xiao, Master

CONTACT

54845721; eunice7@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Investigators are blinded to implant allocation except for the operating surgeon, who cannot be blinded due to the inherent differences in implant instrumentation and design. Participants and outcomes assessors remain blinded throughout the study. The allocation sequence is concealed using sequentially numbered, opaque, sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)