Knee OsteoarthritisTOPKATNCT01352247
Total or Partial Knee Arthroplasty Trial
A study testing Unicompartmental Knee Replacement and Total Knee Replacement in people with Knee Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Unicompartmental Knee Replacement and Total Knee Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to 20 Jun 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medial compartment osteoarthritis with exposed bone on both femur and tibia
- Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- Full thickness and good quality lateral cartilage present
- Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament)
- Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Who cannot join
- Require revision knee replacement surgery
- Have rheumatoid arthritis or other inflammatory disorders
- Are unlikely to be able to perform required clinical assessment tasks
- Have symptomatic foot, hip or spinal pathology
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy
- Previously had septic arthritis
- Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nuffield Orthopaedic Centre NHS Trust
Oxford, Oxfordshire, OX3 7LD
About this study
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support either practice. Each intervention is considered standard care. There exists little evidence, however, to prove the clinical and cost effectiveness of either management option.
The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis. This will be examined using an appropriate patient base and long term assessments.
Read more
The trial has a combined device/expertise based allocation depending on the local situation. Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR, randomisation and allocation can be based on "device" (UKR or TKR). The same surgeon will perform the operation for both arms of the study.
For surgeons who hold a preference for one treatment over the other, an "expertise" based randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients recruited to the study from these sites will be randomised to one of the treatment options and treated by the appropriate surgeon. In such cases the patient is internally referred to the other surgeon's operating list.
Patients will be recruited by their consultant knee surgeons in collaboration with the local research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the trial.
Read the detailed description
The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. The randomised controlled trial design will help reduce and prevent potential bias influencing the evaluation.
Participants will be randomised to either UKR or TKR. The trial has a combined equipoise/expertise approach. It enables surgeons who are not in equipoise to deliver only one of the two operations while also allowing surgeons in equipoise to provide both operations. A surgeon who is in equipoise ('equipoise surgeon') and has sufficient experience to perform both TKR and UKR will deliver the allocated operation (UKR or TKR). The same surgeon will perform the operation for both arms of the study.
Not all surgeons are able to exhibit this equipoise. They may hold a preference for one treatment over the other often due to experience/expertise with one type of operation. Interestingly, a surgeon may also believe the patient may benefit from one particular operation even though they may not be able to perform it themselves.
Equipoise is difficult to investigate or establish. Self declaration has been used as the main approach but in order to sufficiently secure this state the following aspects are important:
- The equipoise considered must be patient- or individual-based equipoise rather than an overall or general category equipoise based on operation type. The surgeon must consider their position for each individual patient. Only if they believe that either operation will be suitable for an individual patient can the patient then be recruited.
- No surgeon will ever knowingly perform what they consider a substandard surgical procedure.
In order to complete the trial by seeking to maximise surgeon participation, an 'expertise'-based delivery of the intervention will also occur. For this approach there must be a surgeon with expertise in TKR and a surgeon with expertise in UKR in the same centre who will act together as a 'delivery unit'. Patients recruited to the study who are under the care of such a surgeon ('expertise surgeon') will be randomised to one of the two groups and treated by the appropriate surgeon. This 'expertise' approach allows for those UKR surgeons who work alongside TKR surgeons to team up and participate in the study. Subsequent surgery may be carried out by a surgeon different to that at the initial consultation. In such cases the patient is internally referred to the other surgeon's operating list. No restriction is made upon the number of delivery units within a centre. A surgeon can only be in one delivery unit, that is, they are either an 'equipoise surgeon' or an 'expertise surgeon'.
- Conditions
- Knee Osteoarthritis
- Being tested
- Unicompartmental Knee Replacement, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental Knee ReplacementProcedure or surgery
A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure.
Total Knee ReplacementProcedure or surgery
A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position.
| Study group | Role | What they receive |
|---|---|---|
| Unicompartmental Knee Replacement | Experimental | TOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded.
A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure. Receives: Procedure: Unicompartmental Knee Replacement |
| Total Knee Replacement | Experimental | TOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded.
A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position. Receives: Procedure: Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Function
This will be measured by using the Oxford Knee Score, a patient reported outcome questionnaire.
Measured: Year 5 (additional extended follow-up to 10 years)
Secondary outcomes (4)
Range of Motion and Function
This will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function.
Measured: Year 5
Activity level
This will be measured using two patient reported questionnaires, the University of California, Los Angeles (UCLA) Activity Score and the High Activity Arthroplasty Score.
Measured: Year 5 (additional extended follow-up to 10 years)
Economic Evaluation
The EuroQol (EQ-5D) a patient reported questionnaire will provide data for economic evaluation.
Measured: Year 5 (additional extended follow-up to 10 years)
Patient Satisfaction
Patient satisfaction will be measured using the Lund Score.
Measured: Year 5 (additional extended follow-up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2018
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen
- Responsible party
- Sponsor
- Investigators
- David Beard, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352247
- Sponsor's protocol ID
- 09/H0606/88
- Other IDs
- ISRCTN03013488
- Acronym
- TOPKAT
- Status last verified
- May 2024
- First submitted
- 20 Apr 2011
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK. Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT. Health Technol Assess. 2020 Apr;24(20):1-98. doi: 10.3310/hta24200.
PubMed 32369436Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.
PubMed 31326135Beard DJ, Davies LJ, Cook JA, MacLennan G, Hudson J, Price AJ, Carr AJ, Little M, Leal J, Fitzpatrick R, Murray DW, Campbell MK; TOPKAT Study Group. Assessing clinical and cost effectiveness of total versus partial knee replacement (TOPKAT): 10-year follow-up of a multicentre, randomised controlled trial. Lancet Rheumatol. 2026 Feb;8(2):e116-e126. doi: 10.1016/S2665-9913(25)00250-4. Epub 2025 Nov 18.
PubMed 41270774Patel R, Tilling K, Lawlor DA, Howe LD, Bogdanovich N, Matush L, Nicoli E, Kramer MS, Martin RM. Socioeconomic differences in childhood length/height trajectories in a middle-income country: a cohort study. BMC Public Health. 2014 Sep 8;14:932. doi: 10.1186/1471-2458-14-932.
PubMed 25200513Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, Doll H, Campbell H, Arden N, Cooper C, Davies L, Murray D. Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013 Sep 12;14:292. doi: 10.1186/1745-6215-14-292.
PubMed 24028414
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total or Partial Knee Arthroplasty Trial
- ClinicalTrials.gov ID
- NCT01352247
- Acronym / sponsor ID
- TOPKAT / 09/H0606/88
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Aberdeen
- Study start
- Jan 2010 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 11 May 2011 (estimated)
- 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.
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support either practice. Each intervention is considered standard care. There exists little evidence, however, to prove the clinical and cost effectiveness of either management option.
The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis. This will be examined using an appropriate patient base and long term assessments.
The trial has a combined device/expertise based allocation depending on the local situation. Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR, randomisation and allocation can be based on "device" (UKR or TKR). The same surgeon will perform the operation for both arms of the study.
For surgeons who hold a preference for one treatment over the other, an "expertise" based randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients recruited to the study from these sites will be randomised to one of the treatment options and treated by the appropriate surgeon. In such cases the patient is internally referred to the other surgeon's operating list.
Patients will be recruited by their consultant knee surgeons in collaboration with the local research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the trial.
Detailed description
The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. The randomised controlled trial design will help reduce and prevent potential bias influencing the evaluation.
Participants will be randomised to either UKR or TKR. The trial has a combined equipoise/expertise approach. It enables surgeons who are not in equipoise to deliver only one of the two operations while also allowing surgeons in equipoise to provide both operations. A surgeon who is in equipoise ('equipoise surgeon') and has sufficient experience to perform both TKR and UKR will deliver the allocated operation (UKR or TKR). The same surgeon will perform the operation for both arms of the study.
Not all surgeons are able to exhibit this equipoise. They may hold a preference for one treatment over the other often due to experience/expertise with one type of operation. Interestingly, a surgeon may also believe the patient may benefit from one particular operation even though they may not be able to perform it themselves.
Equipoise is difficult to investigate or establish. Self declaration has been used as the main approach but in order to sufficiently secure this state the following aspects are important:
- The equipoise considered must be patient- or individual-based equipoise rather than an overall or general category equipoise based on operation type. The surgeon must consider their position for each individual patient. Only if they believe that either operation will be suitable for an individual patient can the patient then be recruited.
- No surgeon will ever knowingly perform what they consider a substandard surgical procedure.
In order to complete the trial by seeking to maximise surgeon participation, an 'expertise'-based delivery of the intervention will also occur. For this approach there must be a surgeon with expertise in TKR and a surgeon with expertise in UKR in the same centre who will act together as a 'delivery unit'. Patients recruited to the study who are under the care of such a surgeon ('expertise surgeon') will be randomised to one of the two groups and treated by the appropriate surgeon. This 'expertise' approach allows for those UKR surgeons who work alongside TKR surgeons to team up and participate in the study. Subsequent surgery may be carried out by a surgeon different to that at the initial consultation. In such cases the patient is internally referred to the other surgeon's operating list. No restriction is made upon the number of delivery units within a centre. A surgeon can only be in one delivery unit, that is, they are either an 'equipoise surgeon' or an 'expertise surgeon'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicompartmental Knee Replacement | Experimental | Procedure: Unicompartmental Knee ReplacementTOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded. A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure. |
| Total Knee Replacement | Experimental | Procedure: Total Knee ReplacementTOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded. A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medial compartment osteoarthritis with exposed bone on both femur and tibia
- Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- Full thickness and good quality lateral cartilage present
- Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament)
- Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Key exclusion criteria (7 listed)
- Require revision knee replacement surgery
- Have rheumatoid arthritis or other inflammatory disorders
- Are unlikely to be able to perform required clinical assessment tasks
- Have symptomatic foot, hip or spinal pathology
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy
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 |
|---|---|---|
| Unicompartmental Knee ReplacementA partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure. | Procedure or surgery | Unicompartmental Knee Replacement |
| Total Knee ReplacementA total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position. | Procedure or surgery | Total Knee Replacement |
Primary outcome
Pain and Function
Time frame: Year 5 (additional extended follow-up to 10 years)
This will be measured by using the Oxford Knee Score, a patient reported outcome questionnaire.
4 secondary outcomes
Range of Motion and Function
Time frame: Year 5
Activity level
Time frame: Year 5 (additional extended follow-up to 10 years)
Economic Evaluation
Time frame: Year 5 (additional extended follow-up to 10 years)
Patient Satisfaction
Time frame: Year 5 (additional extended follow-up to 10 years)
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 4 Apr 2025.
- Background: PubMed 32369436Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK. Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT. Health Technol Assess. 2020 Apr;24(20):1-98. doi: 10.3310/hta24200.
- Results publication: PubMed 31326135Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.
- Derived from this study: PubMed 41270774Beard DJ, Davies LJ, Cook JA, MacLennan G, Hudson J, Price AJ, Carr AJ, Little M, Leal J, Fitzpatrick R, Murray DW, Campbell MK; TOPKAT Study Group. Assessing clinical and cost effectiveness of total versus partial knee replacement (TOPKAT): 10-year follow-up of a multicentre, randomised controlled trial. Lancet Rheumatol. 2026 Feb;8(2):e116-e126. doi: 10.1016/S2665-9913(25)00250-4. Epub 2025 Nov 18.
- Derived from this study: PubMed 25200513Patel R, Tilling K, Lawlor DA, Howe LD, Bogdanovich N, Matush L, Nicoli E, Kramer MS, Martin RM. Socioeconomic differences in childhood length/height trajectories in a middle-income country: a cohort study. BMC Public Health. 2014 Sep 8;14:932. doi: 10.1186/1471-2458-14-932.
- Derived from this study: PubMed 24028414Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, Doll H, Campbell H, Arden N, Cooper C, Davies L, Murray D. Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013 Sep 12;14:292. doi: 10.1186/1745-6215-14-292.
- Trial WebsiteLink provided by the sponsor.
- Surgical Intervention Trials Unit (SITU): Coordinating CentreLink provided by the sponsor.
- 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.
David Beard, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental Knee Replacement and Total Knee Replacement in people with Knee Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
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 5 inclusion and 7 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 4 Apr 2025. 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 United Kingdom. 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?
Pain and Function (time frame: Year 5 (additional extended follow-up to 10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352247, which also lists 5 linked publications.
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 4 Apr 2025.