A Comparison of Patients Receiving a Unicompartmental Knee Replacement With Robotic Assistance or With Conventional Instrumentation

Smith & Nephew

Status

Withdrawn

Conditions

Osteoarthritis

Joint Diseases

Arthritis

Knee

Musculoskeletal Diseases

Rheumatic Diseases

Treatments

Procedure: Non-robotic conventional instrumentation

Device: NAVIO/CORI Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04992078

NAVIO+JOURNEYUNI.2021.02

Details and patient eligibility

About

A unicompartmental (partial) knee replacement (UKR) is the removal of one part of the knee joint (a condyle), that has become damaged due to osteoarthritis, and replacing it with an artificial implant. The placement of these artificial implants and how they are aligned with each other is important because they can impact overall knee function and the long-term survival of the implant. A UKR is a highly effective, recognised procedure for patients with end-stage osteoarthritis affecting one compartment of the knee joint. The functional outcomes following UKA are at a minimum of equivalence to total knee arthroplasty procedures, with some recent literature demonstrating improved functional patient reported outcome scores.

There have been significant developments in knee replacement surgery over recent years. In particular, the introduction of robotic surgical systems, such as the NAVIO and CORI systems (Smith+Nephew Plc). These systems are hand-held devices which can support the surgeon with the knee replacement procedure, the systems are image-free and do not require the patient to undergo any scans (such as CT scans).

Comparisons of robotic systems to conventional instruments have demonstrated that robotic platforms produce fewer positioning errors in total knee replacement. This can result in more precise knee alignment and better outcomes following surgery. With both the NAVIO and CORI Surgical Systems there is a reduction in radiation exposure due to them being image-free.

At present, there is some evidence available for the long-term outcomes of knee replacement implanted using robotic assistance (i.e. 2-10 years) however this study is designed to look at the early outcomes following UKR. There is no literature to date to show that robotic-assisted UKR is superior to conventional methods, within the early post-operative period (up to 12 months).

This study is designed to show that the NAVIO/CORI surgical systems are better than conventional methods for UKR. The hypothesis is that they will be cost-effective, will reduce the time a patient spends in hospital following their surgery, will improve patient satisfaction during the early recovery period and will improve the patient's early post-operative mobility and function.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must provide written informed consent
Subject must be aged 18 years or older at the time of surgery
Subject is listed for a primary unicompartmental knee replacement (UKR)
The indication for the UKR is primary arthritis of the knee joint involving one compartment
The subject agrees to give informed consent to participate in the study including consenting to any incidental findings being reported to their General Practioner (GP)
The subject agrees to consent to and to follow the study visit schedule
The subject plans to be available throughout the 1-year post-operative period
Routine radiographic assessment is possible

Exclusion criteria

The subject undergoes a robotic-assisted UKR on the index joint as a revision for a previously failed surgery, or there is a need for complex implants, or any other implant than a standard unicompartmental knee arthroplasty (UKA)
Subject is listed for a simultaneous bilateral UKR
Subject does not understand written or spoken English used in the informed consent form
Subject has active infection or sepsis
Subject is to have a Smith+Nephew Journey II UNI implanted by non-robotic conventional instrumentation
Subject is not available throughout the 1-year post-operative period
Subject, in the opinion of the investigator, has a neuromuscular disorder that prohibits control of the index joint
Subject is undergoing the surgery as a private patient
Patients who, in the opinion of the clinical staff, do not have capacity to give consent
Women who are pregnant
Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study