NCT04976972

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

A Prospective, Multi-Centre, Randomised Controlled Study to Evaluate the Clinical, Health Economic and Patient Reported Outcomes Following Total Knee Arthroplasty With a Robotic Assisted Technique

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A total knee replacement is the removal of parts of the knee joint, that have become damaged due to osteoarthritis, and replacing these with artificial implants. 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. It is reported that up to 34% of all patients following total knee replacement (TKR) have poor outcomes functionally. 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). The NAVIO and CORI Surgical 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). During the surgery, the surgeon uses the NAVIO/CORI hand-held device to map specific landmarks within the knee joint and determines the desired alignment using associated computer software. The tools to remove the bone and place the implants are controlled by the surgeon with the guidance of the NAVIO/CORI software. 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 total knee replacement implanted using robotic assistance (i.e. 2-10 years) however this study is designed to look at the early outcomes following TKR. There is no literature to date to show that robotic-assisted TKR 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 TKR. 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.

Conditions

• Arthritis
• Osteoarthritis
• Knee
• Joint Diseases
• Musculoskeletal Diseases
• Rheumatic Diseases

Interventions

Type	Name	Description
DEVICE	NAVIO/CORI Surgical System	Total knee replacement with robotic assistance
PROCEDURE	Non-robotic conventional instrumentation	Total knee replacement with non-robotic conventional instrumentation

Timeline

• Start date: 2021-09-30
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-07-26
• Last updated: 2022-07-11

Locations

10 sites across 2 countries: Ireland, United Kingdom

Regulatory

• FDA-regulated device study