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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04976972
• Other study ID #: NAVIO.2021.01
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2022
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• NAVIO/CORI Surgical System
Total knee replacement with robotic assistance

Procedure:
• Non-robotic conventional instrumentation
Total knee replacement with non-robotic conventional instrumentation

Locations

Country	Name	City	State
Ireland	Kilcreene Regional Orthopaedic Hospital	Kilkenny
United Kingdom	Royal Orthopaedic Hospital	Birmingham	West Midlands
United Kingdom	Colchester Hospital University NHS Foundation Trust	Colchester
United Kingdom	Central Middlesex Hospital	London
United Kingdom	St Mary's Hospital	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	The Friarage Hospital	Norwich
United Kingdom	Royal Berkshire NHS Trust	Reading
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	St Albans City Hospital	St Albans

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timed Up and Go (TUG) Test	The TUG test measures the time taken by the patient (in seconds) to rise from an armchair, walk 3 metres, turn round and return to sitting in the same chair, without physical assistance. The time taken to complete the test is strongly correlated to the level of functional mobility. The post-operative measurements will be compared to the baseline (pre-operative) time.	Up to 1-year post-operation
Other	6-Minute Walk (6MW) Test	The 6MW test measures the total distance walked in metres over a 6-minute duration, this test has been validated as a measure of functional performance following knee arthroplasty. The post-operative measurements will be compared to the baseline (pre-operative) distance.	Up to 1-year post-operation
Other	Tibial Sagittal Alignment	The tibial sagittal alignment (tibial slope) in degrees will be determined by measuring the angle between the tibial implant (bone interface) (or in the native knee the highest post between anterior and posterior aspects of tibia) and the tibial mechanical axis.; The post-operative measurements will be compared to the baseline (pre-operative) measurements.	Up to 1-year post-operation
Other	Femoral Sagittal Alignment	The femoral sagittal alignment (flexion) in degrees will be calculated by measuring the angle between the femoral mechanical axis and the femoral implant axis on the box or pegs.; The post-operative measurements will be compared to the baseline (pre-operative) measurements.	Up to 1-year post-operation
Other	Coronal Alignment	The femoral coronal alignment (MDFA) will be obtained by measuring the angle between the femoral mechanical axis and the medial to lateral axis of the condylar implant or femoral joint line.; The tibial coronal alignment (MPTA) will be calculated by measuring the angle between the tibial mechanical axis and the medial to lateral axis of the tibial implant or tibial joint line.; HKAA =MDFA + MPTA; HKAA, hip-knee-ankle angle; MDFA, medial distal femoral angle; MPTA, medial proximal tibial angle; The post-operative measurements will be compared to the baseline (pre-operative) measurements.	Up to 1-year post-operation
Other	Mechanical Axis Alignment	The mechanical axis alignment (MAA) will be measured from the long-leg radiographs and compared to the baseline (pre-operative) measurements.; Alignment will be calculated using measurements taken through the centre of the hip (centre of the spherical femoral head), centre of the knee (centre of the tibial plateau) and centre of the ankle (centre of the talus).	Up to 1-year post-operation
Other	Radiographic Assessment	Radiographic assessment of the antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration.	Up to 1-year post-operation
Primary	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	Oxford Knee Score (OKS)	The OKS contains 12 equally weighted questions on activities of daily living. Responses to each question range 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. The change from the baseline scores will be determined for each participant.	Up to 1-year post-operation
Secondary	Oxford Arthroplasty Early Recovery Score (OARS)	Subjects are asked to complete data regarding how they're feeling around four domains: Pain, Sleep, Nausea and feeling unwell, and Mobility. The OARS questionnaire is scored 0-100 with zero being a poor recovery and 100 being positive and indicative of a good recovery.	Up to 6 weeks post-operation
Secondary	Oxford Arthroplasty Early Change Score (OACS)	Subjects are asked to score how they feel after their surgery, compared to before, concentrating on areas such as ability, pain, overall feelings etc. The OACS questionnaire is scored from negative 50 to positive 50 with minus 50 being much worse than before surgery to 50 being much better than before surgery. Zero indicates no change from self-reported pre-operative health status.	Up to 6 weeks post-operation
Secondary	Short-Form 12 Health Questionnaire (SF-12)	The SF-12 is a health-related quality of life questionnaire consisting of 12 questions that measure eight health domains, taken from the original SF-36 questionnaire. The calculations of the Physical and Mental Health Composite scores produce a range of 0-100, a score of zero indicates the lowest level of health and 100 the highest level of health. The change from the baseline scores will be determined for each participant.	Up to 1-year post-operation
Secondary	EuroQol Five-Dimensional Five-Level (EQ-5D-5L)	The EQ-5D-5L is a health-related quality of life score comprising of 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ Visual Analogue Scale (EQ-VAS). Patients are asked to rate their level of impairment across each of the domains. Health states are converted into a single index utility score using a scoring algorithm, a score of 1.0 indicates the best health state, lower scores indicate poorer health states. The change from the baseline scores will be determined for each participant.	Up to 1-year post-operation
Secondary	EuroQol Visual Analogue Scale (EQ-VAS)	The EQ-VAS provides a single global rating of self-perceived health, patients are asked to score their health on a scale of 0-100mm which represents the worst health they can imagine (a score of 0) and the best health they can imagine (a score of 100). The change from the baseline scores will be determined for each participant.	Up to 1-year post-operation
Secondary	Visual Analogue Score (VAS)-PAIN	Subjects will be asked to complete their pain levels on a scale of 0-100, 0 being no pain experienced and 100 meaning the worst pain possible. The change from the baseline scores will be determined for each participant.	Up to 1-year post-operation