ArthroplastyCORI RCT TKANCT04848896
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
A study testing CORI Robotics and Conventional Procedure in people with Arthroplasty and Replacement, run by Smith & Nephew, Inc. at 4 sites in 4 countries.
Trial summary
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- CORI Robotics and Conventional Procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 12 Feb 2022to 2 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
- Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis
- Requires correction of functional deformity
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- 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 join
- 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 receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
- Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
- 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).
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- 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 currently enrolled in another orthopedic clinical trial study.
- 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 is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Background:
REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA).
Read more
Purpose:
This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments.
Research participants / locations:
80 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be roughly 40 patients having TKA using CORI and 40 patients having TKA using conventional procedure.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- CORI Robotics, Conventional Procedure
- Keywords
- Osteoarthritis, Total Knee Arthroplasty (TKA)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORI RoboticsDevice
Total knee arthroplasty (TKA) treated with CORI Robotics System.
Conventional ProcedureProcedure or surgery
Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| CORI | Experimental | Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with CORI Robotics System. Receives: Device: CORI Robotics |
| Conventional Procedure | Active comparator | Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation. Receives: Procedure: Conventional Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Leg Alignment
Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees.
Measured: 6 weeks
Secondary outcomes (6)
Component Alignment
Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery
Measured: 6 weeks
Radiographic Assessment
Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis \& implant migration.
Measured: 12 months and 24 months
2011 Knee Society Score (KSS)
The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in TKA subjects. The 2011 Knee Society Score consists of 4 separate subscales:
- An "Objective" Knee Score (seven items: 100 points)
- A Patient Satisfaction Score (five items: 40 points)
- A Patient Expectation Score (three items: 15 points)
- A Functional Activity Score (19 items: 100 points).
A higher number is a better outcome.
Measured: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Oxford Knee Score (OKS)
To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in TKA subjects. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Measured: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Forgotten Joint Score (FJS)
To assess joint-specific patient reported outcomes in TKA subjects. Responses to 12 questions are recorded with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome.
Measured: 6 weeks, 6 months, 12 months and 24 months
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
To assess the subject's health state in TKA subjects. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.
Measured: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Feb 2022
- Primary completion2 Jun 2026
- Study completion2 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Montani, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848896
- Sponsor's protocol ID
- CORI.2020.08
- Acronym
- CORI RCT TKA
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
- ClinicalTrials.gov ID
- NCT04848896
- Acronym / sponsor ID
- CORI RCT TKA / CORI.2020.08
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Osteoarthritis, Total Knee Arthroplasty (TKA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jul 2028 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA).
Purpose:
This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments.
Research participants / locations:
80 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be roughly 40 patients having TKA using CORI and 40 patients having TKA using conventional procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORI | Experimental | Device: CORI RoboticsSubjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with CORI Robotics System. |
| Conventional Procedure | Active comparator | Procedure: Conventional ProcedureSubjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
- Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- 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.
Key exclusion criteria (15 listed)
- 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 receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
- Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
- Subject does not understand the language used in the Informed Consent Form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORI RoboticsTotal knee arthroplasty (TKA) treated with CORI Robotics System. | Device | CORI |
| Conventional ProcedureTotal knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation. | Procedure or surgery | Conventional Procedure |
Primary outcome
Post-operative Leg Alignment
Time frame: 6 weeks
Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees.
6 secondary outcomes
Component Alignment
Time frame: 6 weeks
Radiographic Assessment
Time frame: 12 months and 24 months
2011 Knee Society Score (KSS)
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Oxford Knee Score (OKS)
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Forgotten Joint Score (FJS)
Time frame: 6 weeks, 6 months, 12 months and 24 months
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Montani study director
Smith & Nephew, Inc.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORI Robotics and Conventional Procedure in people with Arthroplasty and Replacement, run by Smith & Nephew, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, China, Hong Kong, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Leg Alignment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.