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

Smith & Nephew, Inc.126 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Arthroplasty Replacement Knee

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Component Alignment: Femoral Antero-Posterior (A/P) Angle

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.

Time frame: 6 weeks

Component Alignment: Tibial Antero-Posterior (A/P) Angle

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.

Time frame: 6 weeks

Component Alignment: Total Valgus Angle

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.

Time frame: 6 weeks

Component Alignment: Femoral Flexion Angle

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.

Time frame: 6 weeks

Component Alignment: Tibial Lateral Angle

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.

Time frame: 6 weeks

Radiographic Assessment: Radiographic Findings

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

Time frame: 12 months

2011 Knee Society Score (KSS): Objective Score

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).