Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

A Prospective, Multi-center, Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04786119

Enrollment

126

Registered

2021-03-08

Start date

2021-02-17

Completion date

2024-09-10

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Knee, Replacement

Keywords

Unicompartmental Knee Arthroplasty, Total Knee Arthroplasty

Brief 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. 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. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).

Interventions

DEVICECORI Robotics

Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject's unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment. * Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B. * A. Subject requires a cemented UKA as a primary indication due to any of the following conditions: 1. Non-inflammatory degenerative joint disease, including osteoarthritis 2. Avascular necrosis 3. Requires correction of functional deformity 4. Requires treatment of fractures that were unmanageable using other techniques * B. Subject requires a cemented TKA as a primary indication due to any of the following condition: 1. Degenerative joint disease, including osteoarthritis 2. Rheumatoid arthritis 3. Avascular necrosis 4. Requires correction of functional deformity 5. 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 one (1) year postoperative follow-up. * Routine radiographic assessment is possible. * Subject able to follow instructions and deemed capable of completing all study questionnaires.

Exclusion criteria

* Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA or TKA (e.g. stems, augments, or custom made devices). * Subject has been diagnosed with post-traumatic arthritis * Subject receives bilateral UKA or TKA * Subject does not understand the language used in the Informed Consent Form. * Subject does not meet the indication or is contraindicated for UKA or TKA according to 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 or UKA 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, mental retardation, 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 ISO 14155 Section 3.55.

Design outcomes

Primary

Measure	Time frame	Description
Post-Operative Leg Alignment	6 weeks	The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Percentage of Knees Achieving Post-Operative Leg Alignment	6 weeks	The percentage of knees achieving post-operative leg alignment taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

Secondary

Measure	Time frame	Description
Component Alignment: Total Valgus Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.
Component Alignment: Femoral Flexion Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle is obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.
Component Alignment: Tibial Lateral Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view tibial angle is the angle obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.
Radiographic Assessment: Radiographic Findings	12 months	Radiographic assessment on antero-posterior (A/P) and lateral (L) views were performed to identify radiographic findings for the presence of radiolucent lines, osteolysis and implant migration. The number of participants with radiographic findings were categorized as one of the following: * Yes * No * Missing
2011 Knee Society Score (KSS): Objective Score	Pre-op, 6 weeks, 6 months and 12 months	The 2011 Knee Society Score Objective score is completed by the surgeon and assesses the condition of the knee based on factors like pain, alignment, ligament stability, and range of motion. The Objective score ranges from 0 to 100, with a higher score indicating better knee function (i.e., a better outcome).
Component Alignment: Femoral Antero-Posterior (A/P) Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle is to be obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.
2011 Knee Society Score (KSS): Satisfaction Score	Pre-op, 6 weeks, 6 months and 12 months	The 2011 Knee Society Score Satisfaction score is a five question 40-point scale completed by the participant. The Satisfaction score ranges from 0 to 40, with a higher score indicating greater satisfaction (i.e., a better outcome).
Oxford Knee Score (OKS)	Pre-op, 6 weeks, 6 months and 12 months	The Oxford Knee Score (OKS) specifically assesses the patient's perspective following knee arthroplasty surgery to indicate knee function. Total overall scores range from 0 to 48. A score of 0 is the worst possible outcome while a score of 48 indicates the best possible outcome.
Forgotten Joint Score (FJS)	6 weeks, 6 months and 12 months	The forgotten Joint Score (FJS) consisted of 12 questions with responses recorded using a five-point Likert response format: Never, almost never, seldom, sometimes and mostly. The item scores were summed and linearly transformed to 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 (i.e., a high score indicated a better outcome).
Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score	Pre-op, 6 weeks, 6 months and 12 months	The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score uses a scale from 0 to 100, with 0 indicating 'the worst health you can imagine' (i.e., a worse outcome) and 100 indicating 'the best health you can imagine' (i.e., a better outcome).
Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score	Pre-op, 6 weeks, 6 months and 12 months	The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., index score) and the EQ Visual Analogue scale (EQ VAS). The descriptive system is a health-related quality of life score that 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. A score of 1 indicates perfect health-related quality of life and 0 indicates no health-related quality of life (i.e., a higher score is a better outcome). Index scores cannot be greater than 1 but could be less than 0.
2011 Knee Society Score (KSS): Function Score	Pre-op, 6 weeks, 6 months and 12 months	The 2011 Knee Society Score Function assesses the participant's ability to perform daily activities and is a component of the overall KSS evaluation. The Function score ranges from 0 to 100, with a higher score indicating better function (i.e., a better outcome).
Component Alignment: Tibial Antero-Posterior (A/P) Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.

Countries

Germany, India, United Kingdom, United States

Participant flow

Recruitment details

Participants recruited across 8 sites in Europe, United Kingdom, India, and the United States.

Participants by arm

Arm	Count
CORI™ in Unicondylar Knee Arthroplasty (UKA) Participants having robotic assisted unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI™ Robotics. CORI™ Robotics: UKA with robotics assisted surgery using the CORI™ Robotics System.	55
CORI™ in Total Knee Arthroplasty (TKA) Participants having robotic assisted total knee arthroplasty (TKA) as decided by their doctor and treated with CORI™ Robotics. CORI™ Robotics: TKA with robotics assisted surgery using the CORI™ Robotics System.	71
Total	126

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	5	5
Overall Study	Subject withdrawn due to exclusion criteria (bilateral knee)	1	0
Overall Study	Withdrawal by Subject	4	5

Baseline characteristics

Characteristic	CORI™ in Unicondylar Knee Arthroplasty (UKA)	Total	CORI™ in Total Knee Arthroplasty (TKA)
Age, Continuous	64.3 years STANDARD_DEVIATION 7.3	64.7 years STANDARD_DEVIATION 8.8	65.0 years STANDARD_DEVIATION 9.9
Body Mass Index (BMI) Class 1 obesity (BMI 30 to < 35)	16 Participants	38 Participants	22 Participants
Body Mass Index (BMI) Class 2 obesity (BMI 35 to <40)	10 Participants	23 Participants	13 Participants
Body Mass Index (BMI) Class 3 obesity (BMI 40 or over)	0 Participants	0 Participants	0 Participants
Body Mass Index (BMI) Healthy weight (BMI 18.5 to < 25)	7 Participants	13 Participants	6 Participants
Body Mass Index (BMI) Overweight (BMI 25 to < 30)	22 Participants	51 Participants	29 Participants
Body Mass Index (BMI) Underweight (BMI < 18.5)	0 Participants	1 Participants	1 Participants
Height	168.6 centimeters (cm) STANDARD_DEVIATION 11	169.5 centimeters (cm) STANDARD_DEVIATION 10.6	170.2 centimeters (cm) STANDARD_DEVIATION 10.4
Primary Diagnosis Osteoarthritis	55 Participants	124 Participants	69 Participants
Primary Diagnosis Rheumatoid arthritis	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Race American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Asian Indian	2 Participants	7 Participants	5 Participants
Race/Ethnicity, Customized Race Black or Arican American	2 Participants	6 Participants	4 Participants
Race/Ethnicity, Customized Race Chinese	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Filipino	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Japanese	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Korean	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Other	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Other Asian	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Vietnamese	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race White Caucasian	51 Participants	112 Participants	61 Participants
Region of Enrollment Germany	15 Participants	36 Participants	21 Participants
Region of Enrollment India	2 Participants	7 Participants	5 Participants
Region of Enrollment United Kingdom	6 Participants	12 Participants	6 Participants
Region of Enrollment United States	32 Participants	71 Participants	39 Participants
Sex: Female, Male Female	29 Participants	67 Participants	38 Participants
Sex: Female, Male Male	26 Participants	59 Participants	33 Participants
Weight	86.4 kilograms (kg) STANDARD_DEVIATION 16.6	87.1 kilograms (kg) STANDARD_DEVIATION 16.7	87.7 kilograms (kg) STANDARD_DEVIATION 16.9

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 55	0 / 71
other Total, other adverse events	17 / 55	26 / 71
serious Total, serious adverse events	2 / 55	10 / 71

Outcome results

Primary

Percentage of Knees Achieving Post-Operative Leg Alignment

The percentage of knees achieving post-operative leg alignment taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

Time frame: 6 weeks

Population: Full analysis set included participants with at least one post-operative assessment up to the primary completion date with data collected for the time frame, procedure type, and outcome indicated.

Arm	Measure	Group	Value (NUMBER)
CORI Robotics	Percentage of Knees Achieving Post-Operative Leg Alignment	Unicondylar Knee Arthroplasty (UKA)	89.36 percentage of knees
CORI Robotics	Percentage of Knees Achieving Post-Operative Leg Alignment	Total Knee Arthroplasty (TKA)	88.71 percentage of knees
CORI Robotics	Percentage of Knees Achieving Post-Operative Leg Alignment	Overall	88.99 percentage of knees

Primary

Post-Operative Leg Alignment

The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).

Time frame: 6 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CORI Robotics	Post-Operative Leg Alignment	Unicondylar Knee Arthroplasty (UKA)	42 Participants
CORI Robotics	Post-Operative Leg Alignment	Total Knee Arthroplasty (TKA)	55 Participants
CORI Robotics	Post-Operative Leg Alignment	Overall	97 Participants

Secondary

2011 Knee Society Score (KSS): Function Score

The 2011 Knee Society Score Function assesses the participant's ability to perform daily activities and is a component of the overall KSS evaluation. The Function score ranges from 0 to 100, with a higher score indicating better function (i.e., a better outcome).

Time frame: Pre-op, 6 weeks, 6 months and 12 months