Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining Versus Bi-Cruciate Stabilized

Sponsor
Chinese University of Hong Kong
Study ID
NCT06838663
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Robotic assisted Cruciate-Retaining (CR) TKA procedures — PROCEDURE
    Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)
  • Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures — PROCEDURE
    Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)

Study Details

The global prevalence of osteoarthritis of the knee with total knee arthroplasty performed is projected to substantially rise in the near future. This phenomenon is also observed in Hong Kong in which more than 4000 elective total joint replacement surgeries were performed in 2021 and over 30,000 patients are on the waiting list where some regions would have to wait for a median of more than 4 years. REAL INTELLIGENCE™ CORI™ (CORI Navigation) is a computer-assisted orthopedic surgical navigation and blurring system. CORI Navigation is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures. CORI Navigation is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Navigation software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module. Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) was designed for more kinematically functional implants that better reconstruct natural knee kinematics for activities of daily living. Surgical implant designs that resect the cruciate ligaments has emerged to simplify implantation and reduce surgical difficulty. The improvement of the biomechanical properties mimicking the natural kinematics of both the BCS and CR TKA may provide an effective solution to patient's dissatisfaction and impaired functional outcomes after surgery.

Key Dates

First listed
Feb 21, 2025
Start date
Jun 30, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic assisted Cruciate-Retaining (CR) TKA procedures
    Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)
  • Experimental: Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures
    Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)

Primary Outcome Measure

Post-operative leg alignment - Standard Radiographic Evaluation [ Time Frame: pre-operatively and 6 weeks, 12 weeks，12months and 24 months after surgery ]

Central Contacts

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