ArthritisNCT04976972
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
A study testing NAVIO/CORI Surgical System and Non-robotic conventional instrumentation in people with Arthritis and Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 10 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Osteoarthritis, Knee
- What is being tested?
- NAVIO/CORI Surgical System and Non-robotic conventional instrumentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Sep 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom9 sites
Royal Orthopaedic Hospital
Birmingham, West Midlands, B31 2AP
Colchester Hospital University NHS Foundation Trust
Colchester, CO4 5JL
Central Middlesex Hospital
London, NW10 7NS
St Mary's Hospital
London, W2 1NY
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
The Friarage Hospital
Norwich
Royal Berkshire NHS Trust
Reading, RG1 5AN
Royal Hallamshire Hospital
Sheffield
St Albans City Hospital
St Albans
About this study
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
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.
Read more
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
- Being tested
- NAVIO/CORI Surgical System, Non-robotic conventional instrumentation
- Keywords
- Robotic, Total Knee Replacement (TKR)
- Medical subject headings
- Arthritis, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVIO/CORI Surgical SystemDevice
Total knee replacement with robotic assistance
Non-robotic conventional instrumentationProcedure or surgery
Total knee replacement with non-robotic conventional instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Total Knee Replacement (R-TKR) | Experimental | NAVIO/CORI Surgical System Receives: Device: NAVIO/CORI Surgical System |
| Conventional-Total Knee Replacement (C-TKR) | Active comparator | Non-robotic conventional instrumentation Receives: Procedure: Non-robotic conventional instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (7)
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.
Measured: Up to 1-year post-operation
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1-year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start30 Sep 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: study protocol is being significantly changed study is therefore being terminated and will re-open under new title and study number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iain McNamara, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976972
- Sponsor's protocol ID
- NAVIO.2021.01
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04976972
- Acronym / sponsor ID
- NAVIO.2021.01
- Conditions
- Arthritis, Osteoarthritis, Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Keywords
- Robotic, Total Knee Replacement (TKR)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study protocol is being significantly changed study is therefore being terminated and will re-open under new title and study number
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Total Knee Replacement (R-TKR) | Experimental | Device: NAVIO/CORI Surgical SystemNAVIO/CORI Surgical System |
| Conventional-Total Knee Replacement (C-TKR) | Active comparator | Procedure: Non-robotic conventional instrumentationNon-robotic conventional instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVIO/CORI Surgical SystemTotal knee replacement with robotic assistance | Device | Robotic-Total Knee Replacement (R-TKR) |
| Non-robotic conventional instrumentationTotal knee replacement with non-robotic conventional instrumentation | Procedure or surgery | Conventional-Total Knee Replacement (C-TKR) |
Primary outcome
Forgotten Joint Score (FJS)
Time frame: Up to 1 year
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.
7 secondary outcomes
Oxford Knee Score (OKS)
Time frame: Up to 1-year post-operation
Oxford Arthroplasty Early Recovery Score (OARS)
Time frame: Up to 6 weeks post-operation
Oxford Arthroplasty Early Change Score (OACS)
Time frame: Up to 6 weeks post-operation
Short-Form 12 Health Questionnaire (SF-12)
Time frame: Up to 1-year post-operation
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
Time frame: Up to 1-year post-operation
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Up to 1-year post-operation
Visual Analogue Score (VAS)-PAIN
Time frame: Up to 1-year post-operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain McNamara principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVIO/CORI Surgical System and Non-robotic conventional instrumentation in people with Arthritis and Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score (FJS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.