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study protocol is being significantly changed study is therefore being terminated and will re-open under new title and study number
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-Total Knee Replacement (R-TKR) | Experimental | NAVIO/CORI Surgical System |
|
| Conventional-Total Knee Replacement (C-TKR) | Active Comparator | Non-robotic conventional instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVIO/CORI Surgical System | Device | Total knee replacement with robotic assistance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iain McNamara | Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kilcreene Regional Orthopaedic Hospital | Kilkenny | R95 DK07 | Ireland | |||
| Royal Orthopaedic Hospital |
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| Non-robotic conventional instrumentation | Procedure | Total knee replacement with non-robotic conventional instrumentation |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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.
The post-operative measurements will be compared to the baseline (pre-operative) measurements. | Up to 1-year post-operation |
| 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 |
| 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 |
| Birmingham |
| West Midlands |
| B31 2AP |
| United Kingdom |
| Colchester Hospital University NHS Foundation Trust | Colchester | CO4 5JL | United Kingdom |
| Central Middlesex Hospital | London | NW10 7NS | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| The Friarage Hospital | Norwich | United Kingdom |
| Royal Berkshire NHS Trust | Reading | RG1 5AN | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| St Albans City Hospital | St Albans | United Kingdom |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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