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Two robot-assisted knee replacement implant types compared in people with knee osteoarthritis

Compares two knee replacement implant designs placed with robotic help in knee osteoarthritis.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining Versus Bi-Cruciate Stabilized
Status
Not yet recruiting
People taking part
60 people, planned
Started
Jun 2025
Expected to end
Jan 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Robotic assisted Cruciate-Retaining (CR) TKA procedures
  • Robotic assisted Bi-Cruciate Stabilized (BCS) TKA procedures
Record updated
24 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need a first cemented knee replacement on one knee. The surgery is done with robot help.

Age
18 years or older (old enough to consent, bones fully grown at surgery).
Sex
All sexes can join.
Disease stage
People who need a first knee replacement for wear-and-tear joint disease such as osteoarthritis, rheumatoid arthritis, bone death from poor blood supply (avascular necrosis), a deformity to correct, or fractures other methods could not treat. They must be able to have robot-assisted knee replacement.
Earlier treatment
The knee must not have had a previous failed knee replacement surgery.

Main reasons for not taking part

  • Need for a repeat knee replacement, complex implants, or replacement of both knees
  • Arthritis caused by an injury (post-traumatic arthritis)
  • Active infection or sepsis, treated or untreated
  • Body mass index (BMI) greater than 40
  • Pregnant or breastfeeding at the time of surgery

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 is pregnant or breast feeding at the time of surgery
  • Subject has active infection or sepsis (treated or untreated)
  • 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
  • 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 is morbidly obese with a body mass index (BMI) greater than 40

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Robotic assisted Cruciate-Retaining (CR) TKA proceduresTreatment being tested

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

  • Robotic assisted Bi-Cruciate Stabilized (BCS) TKA proceduresTreatment being tested

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparative Outcomes of Robotic-Assisted Total Knee Arthroplasty: Cruciate-Retaining (CR) Versus Bi-Cruciate Stabilized (BCS) in a Randomized Controlled Trial
Plain-language title
Two robot-assisted knee replacement implant types compared in people with knee osteoarthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
24 June 2025