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

NCT04976972 | Withdrawn FDA Device

• 1 other identifier: NAVIO.2021.01
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 10

Brief 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

Keywords

Robotic; Total Knee Replacement (TKR)

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score (FJS)

  Subjects are asked to rate their awareness of their knee arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. The change from the baseline scores will be determined for each participant.

  Up to 1 year

Secondary Outcomes (7)

• Oxford Knee Score (OKS)

  Up to 1-year post-operation

• Oxford Arthroplasty Early Recovery Score (OARS)

  Up to 6 weeks post-operation

• Oxford Arthroplasty Early Change Score (OACS)

  Up to 6 weeks post-operation

• Short-Form 12 Health Questionnaire (SF-12)

  Up to 1-year post-operation

• EuroQol Five-Dimensional Five-Level (EQ-5D-5L)

  Up to 1-year post-operation

Other Outcomes (7)

• Timed Up and Go (TUG) Test

  Up to 1-year post-operation

• 6-Minute Walk (6MW) Test

  Up to 1-year post-operation

• Tibial Sagittal Alignment

  Up to 1-year post-operation

Study Arms (2)

Robotic-Total Knee Replacement (R-TKR)

EXPERIMENTAL

NAVIO/CORI Surgical System

Device: NAVIO/CORI Surgical System

Conventional-Total Knee Replacement (C-TKR)

ACTIVE COMPARATOR

Non-robotic conventional instrumentation

Procedure: Non-robotic conventional instrumentation

Interventions

NAVIO/CORI Surgical System DEVICE

Total knee replacement with robotic assistance

Robotic-Total Knee Replacement (R-TKR)

Non-robotic conventional instrumentation PROCEDURE

Total knee replacement with non-robotic conventional instrumentation

Conventional-Total Knee Replacement (C-TKR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 total knee replacement (TKR)
• The indication for the TKR is primary arthritis of the knee joint involving one or more compartments
• 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

You may not qualify if:

• The subject undergoes a robotic-assisted TKR 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 total knee arthroplasty (TKA)
• Subject is listed for a simultaneous bilateral TKR
• 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 BCS 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (10)

Kilcreene Regional Orthopaedic Hospital

Kilkenny, R95 DK07, Ireland

Location

Royal Orthopaedic Hospital

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Colchester Hospital University NHS Foundation Trust

Colchester, CO4 5JL, United Kingdom

Location

Central Middlesex Hospital

London, NW10 7NS, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

The Friarage Hospital

Norwich, United Kingdom

Location

Royal Berkshire NHS Trust

Reading, RG1 5AN, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

St Albans City Hospital

St Albans, United Kingdom

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iain McNamara

  Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: September 30, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (9)