Osteo Arthritis KneeRATKANCT04611815
Robotic-assisted Total Knee Arthroplasty vs. Conventional One
A study testing Total knee arthroplasty, Computer tomography scan and biomechanical assesment in people with Osteo Arthritis Knee and Knee Arthritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing robotic-assisted total knee arthroplasty and conventional one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Knee Arthritis, Knee Pain Chronic
- What is being tested?
- Total knee arthroplasty, Computer tomography scan and biomechanical assesment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2020to 1 Aug 2022
- 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
- Listed for a primary total knee replacement (TKR)
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Who cannot join
- Listed for a single-stage one-sided TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- Inflammatory arthritis
Show all 16Show fewer
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- A contralateral total knee replacement that has been implanted less than one year from the date of consultation
- A contralateral total knee replacement that is severely painful
- Patients on warfarin or novel oral anticoagulants (NOACs)
- Will not be resident in the catchment area for at least 6 months post-surgery
- Undertaking the surgery as a private patient
- Patients who, in the opinion of the clinical staff, do not have capacity to consent
- Patients who are pregnant
- Unable to understand written and spoken Polish
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 04-749
About this study
Official title: Does Robotic-assisted Total Knee Arthroplasty Improves Functional Outcome and Gait Pattern in Comparison to Conventional Total Knee Arthroplasty With Use of Bicruciate-stabilized (BS) Implant? Randmized-controlled Trial
This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing robotic-assisted total knee arthroplasty and conventional one.
Read the detailed description
Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. In recent years, there has been development of high technology tools to help surgeon restoring proper joint biomechanics. Nowadays on the market there are several robots designed to fulfill this function. To date, no studies have investigated the kinematic outcomes of robotic-assisted total knee arthroplasty in comparison to conventional surgery. Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) with use of the combination of either Oxford score or KOOS score with addition of WOMAC and Lysholm scores and CT measurement, both pre- and post-operatively, between robotic-assisted total knee arthroplasty and conventional surgery.
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Knee Pain Chronic
- Being tested
- Total knee arthroplasty, Computer tomography scan, biomechanical assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Participant will undergo robotic-assisted or conventional total knee arthroplasty
Computer tomography scanDiagnostic test
CT scans of the affected knee joint before and after the surgical procedure
biomechanical assesmentDiagnostic test
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted total knee arthroplasty | Active comparator | Patients undergoing robotic-assisted total knee arthroplasty with use of Journey II BCS implants Receives: Procedure: Total knee arthroplasty; Diagnostic Test: Computer tomography scan; Diagnostic Test: biomechanical assesment |
| Conventional total knee arthroplasty | Active comparator | Patients undergoing conventional total knee arthroplasty with use of Journey II BCS implants Receives: Procedure: Total knee arthroplasty; Diagnostic Test: Computer tomography scan; Diagnostic Test: biomechanical assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.
Measured: At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.
Changes in patients reported outcome measures - Knee injury and Osteoarthritis Outcome Score (KOOS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients reported outcome measures - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 96, with lower scores corresponding to better outcomes.
Measured: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients reported outcome measures - Lysholm knee scoring scale
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients range of motion (ROM)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
*We take into consideration the possible use of other PROM questionnaires and analysis of different adverse events depending on the unpredictable circumstances.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Secondary outcomes (17)
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.
Measured: [Time Frame: 1 week and 6-8 weeks post-operatively]
Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)
To explore differences in higher levels of activity and social participation
Measured: Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - Forgotten Joint Score (FJS)
To explore differences in patient's ability to forget about a joint as a result of successful treatment. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: Time Frame: 6-8 weeks and 6 months post-operatively
Changes in patients reported outcomes - UCLA (University of California) score
To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes.
Measured: Time Frame: 6-8 weeks and 12 months post-operatively
Changes in knee range of motion
To explore differences in range of motion (flexion and extension)
Measured: Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively
Changes in pain medication
To asses evolution of post-operative knee pain
Measured: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
arthroplasty related complications
To count and asses all complications that may occur during surgery and in postoperative period
Measured: Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
arthroplasty revision surgeries
To count and asses the reason of all revision surgeries that may occur during postoperative period
Measured: Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
walking abilities
To asses "up and go" time
Measured: Time Frame: 6-8 weeks and 12 months post-operatively
Length of hospital stay
To measure number of days counting from surgery to the discharge
Measured: Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
Biomechanical 3D motion and emg walking outcomes
Overground walking is measured using 3D Motion analysis and electromyography (EMG)
Measured: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Radiological outcome on CT scans
Rotational alignment of the total knee component is assessed by measuring the femoral antetorsion, Alignment of the total knee component is assessed by measuring the tibial tubercle-trochlear groove distance (TT-TG)
Measured: Time Frame: at baseline preoperatively and 6 weeks post- operatively
6- minute walking abilities
to asses pace and model of 6-minute walk
Measured: Time Frame: 6-8 weeks and 12 months post-operatively
Biomechanical stair climbing outcomes
Stair climbing and descending is measured using 3D Motion analysis and EMG
Measured: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical static balance outcomes
Static balance is measured using a force plate
Measured: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical dynamic balance outcomes
Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT)
Measured: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Leg muscle strength outcomes
Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.
Measured: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartosz M. Maciąg, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611815
- Sponsor's protocol ID
- WarsawMU/RATKA
- Acronym
- RATKA
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2020
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Robotic-assisted Total Knee Arthroplasty Improves Functional Outcome and Gait Pattern in Comparison to Conventional Total Knee Arthroplasty With Use of Bicruciate-stabilized (BS) Implant? Randmized-controlled Trial
- ClinicalTrials.gov ID
- NCT04611815
- Acronym / sponsor ID
- RATKA / WarsawMU/RATKA
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 2 Nov 2020 (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.
This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing robotic-assisted total knee arthroplasty and conventional one.
Detailed description
Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. In recent years, there has been development of high technology tools to help surgeon restoring proper joint biomechanics. Nowadays on the market there are several robots designed to fulfill this function. To date, no studies have investigated the kinematic outcomes of robotic-assisted total knee arthroplasty in comparison to conventional surgery. Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) with use of the combination of either Oxford score or KOOS score with addition of WOMAC and Lysholm scores and CT measurement, both pre- and post-operatively, between robotic-assisted total knee arthroplasty and conventional surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted total knee arthroplasty | Active comparator | Procedure: Total knee arthroplasty, Diagnostic Test: Computer tomography scan, Diagnostic Test: biomechanical assesmentPatients undergoing robotic-assisted total knee arthroplasty with use of Journey II BCS implants |
| Conventional total knee arthroplasty | Active comparator | Procedure: Total knee arthroplasty, Diagnostic Test: Computer tomography scan, Diagnostic Test: biomechanical assesmentPatients undergoing conventional total knee arthroplasty with use of Journey II BCS implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Listed for a primary total knee replacement (TKR)
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Key exclusion criteria (16 listed)
- Listed for a single-stage one-sided TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
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 |
|---|---|---|
| Total knee arthroplastyParticipant will undergo robotic-assisted or conventional total knee arthroplasty | Procedure or surgery | Conventional total knee arthroplasty, Robotic-assisted total knee arthroplasty |
| Computer tomography scanCT scans of the affected knee joint before and after the surgical procedure | Diagnostic test | Conventional total knee arthroplasty, Robotic-assisted total knee arthroplasty |
| biomechanical assesmentParticipants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively | Diagnostic test | Conventional total knee arthroplasty, Robotic-assisted total knee arthroplasty |
Primary outcome
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time frame: At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.
Changes in patients reported outcome measures - Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Changes in patients reported outcome measures - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 96, with lower scores corresponding to better outcomes.
Changes in patients reported outcome measures - Lysholm knee scoring scale
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Changes in patients range of motion (ROM)
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
*We take into consideration the possible use of other PROM questionnaires and analysis of different adverse events depending on the unpredictable circumstances.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
17 secondary outcomes
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time frame: [Time Frame: 1 week and 6-8 weeks post-operatively]
Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)
Time frame: Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - Forgotten Joint Score (FJS)
Time frame: Time Frame: 6-8 weeks and 6 months post-operatively
Changes in patients reported outcomes - UCLA (University of California) score
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Changes in knee range of motion
Time frame: Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively
Changes in pain medication
Time frame: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
arthroplasty related complications
Time frame: Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
arthroplasty revision surgeries
Time frame: Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
walking abilities
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Length of hospital stay
Time frame: Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
Biomechanical 3D motion and emg walking outcomes
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Radiological outcome on CT scans
Time frame: Time Frame: at baseline preoperatively and 6 weeks post- operatively
6- minute walking abilities
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Biomechanical stair climbing outcomes
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical static balance outcomes
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical dynamic balance outcomes
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Leg muscle strength outcomes
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Bartosz M. Maciąg, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty, Computer tomography scan and biomechanical assesment in people with Osteo Arthritis Knee and Knee Arthritis, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in patients reported outcome measures - Oxford Knee Score (OKS) (time frame: At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.). The study lists 6 primary outcomes in all. 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 15 Sep 2022.