Health TrialsbyHealthPanel

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

ConditionsArthroplastyReplacementKnee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.

About this trial

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:

140 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 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.

Non-inflammatory degenerative joint disease, including osteoarthritis

Rheumatoid arthritis

Avascular necrosis

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CORI Robotics

    Device

    Total knee arthroplasty (TKA) treated with CORI Robotics System.

  • Conventional Procedure

    Procedure/Surgery

    Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: CORIExperimental treatment 1 intervention
Group B: Conventional ProcedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks

Secondary outcomes

1

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

Time frame
6 weeks
2

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.

Time frame
12 months and 24 months
3

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: 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) 4. A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.

Time frame
Pre-op, 6 weeks, 6 months, 12 months and 24 months
4

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.

Time frame
Pre-op, 6 weeks, 6 months, 12 months and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Smith & Nephew, Inc.

Lead sponsor

Source ClinicalTrials.gov
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