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

Not Applicable

Completed

Conditions: Arthroplasty
Knee
Replacement

Interventions: Device: CORI Robotics

Registration Number: NCT04786119

Lead Sponsor: Smith & Nephew, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CORI Robotics	CORI Robotics	Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Component Alignment - UKA	6 weeks	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 in UKA subjects.
Component Alignment - TKA	6 weeks	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 in TKA subjects
Radiographic Assessment - UKA	12 months	Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis \& implant migration in UKA subjects
Radiographic Assessment - TKA	12 months	Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis \& implant migration in TKA subjects
2011 Knee Society Score (KSS) - UKA	Pre-op, 6 week, 6 month and 12 months	The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in UKA subjects. The 2011 Knee Society Score consists of 4 separate sub-scales: (1) An "Objective" Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.
2011 Knee Society Score (KSS) - TKA	Pre-op, 6 week, 6 month and 12 months	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 sub-scales: (1) An "Objective" Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.
Oxford Knee Score (OKS) - UKA	Pre-op, 6 week, 6 month and 12 months	To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in UKA 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.
Oxford Knee Score (OKS) - TKA	Pre-op, 6 week, 6 month and 12 months	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.
Forgotten Joint Score (FJS) - UKA	6 week, 6 month and 12 months	To assess joint-specific patient reported outcomes in UKA 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.
Forgotten Joint Score (FJS) - TKA	6 week, 6 month and 12 months	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.
Five-level EuroQol Five-dimensional (EQ-5D-5L) VAS & Index Scores - UKA	Pre-op, 6 week, 6 month and 12 months	To assess the subject's health state in UKA 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 raging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.
Five-level EuroQol Five-dimensional (EQ-5D-5L) VAS & Index Scores - TKA	Pre-op, 6 week, 6 month and 12 months	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 raging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.

Trial Locations

Locations (8): Orthopedic Institute of the West
🇺🇸
Phoenix, Arizona, United States
Lokmanya Hospital
🇮🇳
Pune, Maharashtra, India
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Duke Health
🇺🇸
Morrisville, North Carolina, United States
Orthopaedic clinic of the Medical School Hannover
🇩🇪
Hannover, Germany
OrthoNeuro
🇺🇸
New Albany, Ohio, United States
Pius-Hospital Oldenburg
🇩🇪
Oldenburg, Germany
The Royal Orthopaedic Hospital NHS Foundation Trust
🇬🇧
Birmingham, West Midlands, United Kingdom