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

NCT06838663 | Not Yet Recruiting DMC

• 1 other identifier: 2024.599
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty

Keywords

Knee Osteoarthritis; Knee OA; Total Knee Arthroplasty; Robotic-assisted TKA procedure

Outcome Measures

Primary Outcomes (1)

• Post-operative leg alignment - Standard Radiographic Evaluation

  The leg alignment should be measured from an antero-posterior (A/P) view standing weight bearing full leg ('long leg') x-ray. The following axes shall be identified: * Mechanical Axis of the femur: Axis from the center of the femoral head to the center of the distal femur. * Mechanical Axis of the tibia: Axis from the center of the proximal to the center of the distal tibia. Standard radiographic evaluation on antero-posterior (A/P) and lateral (L) views shall be performed 12\&24 months after surgery in order to identify any radiographic observations such as radiolucent lines around the implant components. The presence of radiolucent lines, osteolysis \& implant migration shall be recorded.

  pre-operatively and 6 weeks, 12 weeks，12months and 24 months after surgery

Secondary Outcomes (8)

• 2011 Knee Society Score

  pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery

• Oxford Knee Score

  pre-operative visit and 6 weeks, 6 months, 12 months and 24 months after surgery

• Forgotten Joint Score

  pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery

• Knee Injury and Osteoarthritis Outcome Score

  pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery

• The Western Ontario and McMaster Universities Osteoarthritis Index

  pre-operative visit and 6 weeks, 6 months, 12 months, and 24 months after surgery

Study Arms (2)

Robotic assisted Cruciate-Retaining (CR) TKA procedures

EXPERIMENTAL

Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)

Procedure: Robotic assisted Cruciate-Retaining (CR) TKA procedures

Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures

EXPERIMENTAL

Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)

Procedure: Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures

Interventions

Robotic assisted Cruciate-Retaining (CR) TKA procedures PROCEDURE

Patients who underwent Cruciate Retaining (CR) total knee arthroplasty (TKA)

Robotic assisted Cruciate-Retaining (CR) TKA procedures

Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures PROCEDURE

Patients who underwent Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA)

Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures

Eligibility Criteria

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

You may qualify if:

• Subject is a suitable candidate for a robotic-assisted TKA procedure
• Subject requires a cemented TKA as a primary indication that meets any of the following condition:
• Degenerative joint disease, including osteoarthritis
• Rheumatoid arthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques
• Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
• Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
• Subject plans to be available through two (2) year postoperative follow-up.
• Applicable routine radiographic assessment is possible.

You may not qualify if:

• Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom made devices).
• Subject has been diagnosed with post-traumatic arthritis.
• Subject requires bilateral TKA.
• Subject does not understand the language used in the Informed Consent Form.
• Subject does not meet the indication or is contraindicated for TKA according to the specific Smith Nephew Knee System's Instructions For Use (IFU).
• Subject has active infection or sepsis (treated or untreated).
• Subject is morbidly obese with a body mass index (BMI) greater than 40.
• Subject is pregnant or breast feeding at the time of surgery.
• Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
• Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
• Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Tim-yun Michael Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be randomly assigned to robotic assisted Cruciate-Retaining (CR) or Bi-Cruciate Stabilized (BCS) TKA procedures groups according to a balanced randomization procedure using a 1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication

Locations

HK (1)