Withdrawn before it began
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
NCT04976972 · Smith & Nephew Orthopaedics AG · Updated 11 July 2022
- What is being tested
- NAVIO/CORI Surgical System; Non-robotic conventional instrumentation
- For
- Arthritis; Osteoarthritis; Knee; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. The full rules are on the registry page.
- Where
- Ireland, United Kingdom (10 sites)
- When
- Starts or started 30 Sept 2021, ends 30 Sept 2021. Registered 26 July 2021.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Kilcreene Regional Orthopaedic HospitalKilkenny, Ireland
- Royal Orthopaedic HospitalBirmingham, West Midlands, United Kingdom
- Colchester Hospital University NHS Foundation TrustColchester, United Kingdom
- Central Middlesex HospitalLondon, United Kingdom
- St Mary's HospitalLondon, United Kingdom
- Norfolk and Norwich University HospitalNorwich, United Kingdom
- The Friarage HospitalNorwich, United Kingdom
- Royal Berkshire NHS TrustReading, United Kingdom
- Royal Hallamshire HospitalSheffield, United Kingdom
- St Albans City HospitalSt Albans, United Kingdom
