Osteoarthritis, HipNCT05773261
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
A study testing MobilLINK TrabecuLINK cup and Pinnacle Gription cup in people with Osteoarthritis, Hip, run by Umeå University at 1 site in Sweden.
Trial summary
A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- MobilLINK TrabecuLINK cup and Pinnacle Gription cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 2022to 9 Sep 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
- Age 30-70 years
- Primary osteoarthritis of the hip
- Body Mass Index between 18 and 35 kg/m2
- Willingness and ability to follow clinical investigation protocol
Who cannot join
- Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
- Osteoporosis
- Paget's disease
- Inflammatory arthritis
- Secondary osteoarthritis
- Presence of malignancy in the area of surgery
Show all 12Show fewer
- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
- Previous surgery in the affected hip
- Inclusion of the contralateral hip in this clinical investigation
- Not suited for the clinical investigation for other reason (surgeon's judgment)
- Pregnant or breastfeeding women
- Prison inmate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation
A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.
Read the detailed description
The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.
Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.
In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.
- Conditions
- Osteoarthritis, Hip
- Being tested
- MobilLINK TrabecuLINK cup, Pinnacle Gription cup
- Keywords
- Osteoarthritis, Total hip arthroplasty, Uncemented total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilLINK TrabecuLINK cupDevice
THA with MobilLINK TrabecuLINK cup and LCU stem
Pinnacle Gription cupDevice
THA with Pinnacle Gription cup and Coral stem
| Study group | Role | What they receive |
|---|---|---|
| MobilLINK TrabecuLINK cup | Active comparator | The investigational device in this study is the newly developed MobilLINK TrabecuLINK cup. It will in this study be combined with a uncemented LCU stem.
The MobilLINK TrabecuLINK cups are made from Tilastan, a Ti6A4V alloy. The MobileLINK press-fit shells are hemispheric and polar flattened. An equatorial press-fit is built into the shells for primary stability after cementless implantation. All shells have a polar hole, which is used to connect an impactor handle for implantation of the shell. This polar hole can be closed with a polar screw. The MobileLINK TrabecuLINK shells have a 3D printed trabecular surface structure with a pore size of 610 to 820 μm and a porosity of 70 %. Receives: Device: MobilLINK TrabecuLINK cup |
| Pinnacle Gription Series 100 cup | Active comparator | For the control group a Pinnacle Gription cup series 100 with a apex hole eliminator will be used together with a neutral cross-linked polyethylene (XLPE) Marathon liner (DePuy Synthes by Johnson \& Johnson, Norderstedt, Germany). The Pinnacle Gription cup is a hemispherical, single-geometry, titanium press-fit cup with a solid body. The outer surface consists of a porous coating with 300 μm sintered titanium beads coated with an extra layer of irregularly shaped pure titanium pieces. In cases where no initial stability can be reached when using the Pinnacle 100 series, the Pinnacle Gription sector cup with additional bone screws will be used. The cross-linked Marathon insert is made of 1050 GUR resin, irradiated with 50 kGy, remelted and plasma sterilized.
The Pinnacle Gription cup will be implanted together with a Corail stem (DePuy Synthes). Receives: Device: Pinnacle Gription cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early migration of the cup
Migration of the cup between 3 month and 2 years after implantation of the cup measured with Computed Tomography scan based Micromotion Analysis (CTMA) in mm.
Measured: 2 years after operation
Secondary outcomes (13)
Proximal wear
Liner wear measured as proximal penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
Measured: 5 years after operation
3D wear
Liner wear measured as 3D penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
Measured: 5 years after operation
Long term migratio
Migration of the cup measured in mm with CTMA
Measured: 15 years after operation
Long term wear
Liner wear measured in mm with CTMA
Measured: 15 years after operation
Stem migration
Distal and 3D migration in mm of the stem between post- operative examination and 3 month, 3 month and 2 years, 3 month and 5 years and 3 month and 15 years.
Measured: 15 years
Patient reported outcome with Forgotten Joint Score
Patient-reported outcome measured by Forgotten Joint Score (FSJ). The scores will be summarized and transformed to a scale ranging from 0 to 100, where a high value indicate that the patient tends to be less aware of the affected joint when performing daily activities.
Measured: 15 years after operation
Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score
Patient-reported outcome measured by Hip dysfunction and Osteoarthritis Outcome Score (HOOS). Each of the 5 subscales will get a score of 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms. The subscales will be plotted as a HOOS profile, by connecting the mean scores for all 5 dimensions with a line.
Measured: 15 years after operation
Patient reported outcome with University of California, Los Angeles Activity Score
Patient-reported outcome measured by University of California, Los Angeles Activity Score (UCLA). The patients physical activity level rank from 1 (low) to 10 (high).
Measured: 15 years after operation
Patient reported outcome with EuroQuol 5.
Patient reported health related quality of life, measured by EuroQuol 5 dimensions (EQ-5D). For the calculation of the EQ-5D index the standard value set version 2.1 for Sweden is used. Index scores range from 0 ( 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Measured: 15 years after operation
Reoperations
Incidence and rate of revisions, re-operations and operation-related complications
Measured: 15 years after operation
Osteolysis
Incidence and rate of patients showing osteolysis around the cup on CT scans and/or on x-rays
Measured: 15 years after operation
Precision of migration measurements with CTMA
Precision of migration measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Measured: 1 year after operation
Precision of wear mearurements with CTMA
Precision of wear measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start9 Sep 2022
- Primary completion9 Sep 2026 (estimated)
- Study completion9 Sep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Model description
- Control: Pinnacle Gription series 100 cup with a Marathon liner combined med with a Corail femoral stem. Investigational device: MobilLINK TrabecuLINK cup with X-LINKed liner combined with a LCU femoral stem.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå, Region Västerbotten
- Responsible party
- Sponsor
- Investigators
- Volker Otten, M.D, PhD, Principal investigator, Umeå University hospital/Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773261
- Sponsor's protocol ID
- TrabecuLINK study
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buttaro MA, Onativia JI, Slullitel PA, Andreoli M, Comba F, Zanotti G, Piccaluga F. Metaphyseal debonding of the Corail collarless cementless stem: report of 18 cases and case-control study. Bone Joint J. 2017 Nov;99-B(11):1435-1441. doi: 10.1302/0301-620X.99B11.BJJ-2017-0431.R1.
PubMed 29092981Louboutin L, Viste A, Desmarchelier R, Fessy MH. Long-term survivorship of the Corail standard stem. Orthop Traumatol Surg Res. 2017 Nov;103(7):987-992. doi: 10.1016/j.otsr.2017.06.010. Epub 2017 Aug 1.
PubMed 28778624van der Voort P, Pijls BG, Nieuwenhuijse MJ, Jasper J, Fiocco M, Plevier JW, Middeldorp S, Valstar ER, Nelissen RG. Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies. Acta Orthop. 2015;86(5):575-85. doi: 10.3109/17453674.2015.1043832.
PubMed 25909455Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.
PubMed 18594097Campbell D, Mercer G, Nilsson KG, Wells V, Field JR, Callary SA. Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study. Int Orthop. 2011 Apr;35(4):483-8. doi: 10.1007/s00264-009-0913-z. Epub 2009 Dec 13.
PubMed 20012862Goriainov V, Jones A, Briscoe A, New A, Dunlop D. Do the cup surface properties influence the initial stability? J Arthroplasty. 2014 Apr;29(4):757-62. doi: 10.1016/j.arth.2013.07.007. Epub 2013 Nov 22.
PubMed 24269067Drobniewski M, Borowski A, Synder M, Sibinski M. Results of total cementless hip joint arthroplasty with Corail stem. Ortop Traumatol Rehabil. 2013 Jan-Feb;15(1):61-8. doi: 10.5604/15093492.1032797.
PubMed 23510822
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT05773261
- Acronym / sponsor ID
- TrabecuLINK study
- Conditions
- Osteoarthritis, Hip
- Keywords
- Osteoarthritis, Total hip arthroplasty, Uncemented total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Umeå, Region Västerbotten
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Sep 2026 (estimated)
- Study completion
- 9 Sep 2039 (estimated)
- First posted
- 17 Mar 2023 (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 randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.
Detailed description
The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.
Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.
In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control: Pinnacle Gription series 100 cup with a Marathon liner combined med with a Corail femoral stem. Investigational device: MobilLINK TrabecuLINK cup with X-LINKed liner combined with a LCU femoral stem.
| Arm | Type | Receives |
|---|---|---|
| MobilLINK TrabecuLINK cup | Active comparator | Device: MobilLINK TrabecuLINK cupThe investigational device in this study is the newly developed MobilLINK TrabecuLINK cup. It will in this study be combined with a uncemented LCU stem. The MobilLINK TrabecuLINK cups are made from Tilastan, a Ti6A4V alloy. The MobileLINK press-fit shells are hemispheric and polar flattened. An equatorial press-fit is built into the shells for primary stability after cementless implantation. All shells have a polar hole, which is used to connect an impactor handle for implantation of the shell. This polar hole can be closed with a polar screw. The MobileLINK TrabecuLINK shells have a 3D printed trabecular surface structure with a pore size of 610 to 820 μm and a porosity of 70 %. |
| Pinnacle Gription Series 100 cup | Active comparator | Device: Pinnacle Gription cupFor the control group a Pinnacle Gription cup series 100 with a apex hole eliminator will be used together with a neutral cross-linked polyethylene (XLPE) Marathon liner (DePuy Synthes by Johnson \& Johnson, Norderstedt, Germany). The Pinnacle Gription cup is a hemispherical, single-geometry, titanium press-fit cup with a solid body. The outer surface consists of a porous coating with 300 μm sintered titanium beads coated with an extra layer of irregularly shaped pure titanium pieces. In cases where no initial stability can be reached when using the Pinnacle 100 series, the Pinnacle Gription sector cup with additional bone screws will be used. The cross-linked Marathon insert is made of 1050 GUR resin, irradiated with 50 kGy, remelted and plasma sterilized. The Pinnacle Gription cup will be implanted together with a Corail stem (DePuy Synthes). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
- Age 30-70 years
- Primary osteoarthritis of the hip
- Body Mass Index between 18 and 35 kg/m2
- Willingness and ability to follow clinical investigation protocol
Key exclusion criteria (12 listed)
- Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
- Osteoporosis
- Paget's disease
- Inflammatory arthritis
- Secondary osteoarthritis
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 |
|---|---|---|
| MobilLINK TrabecuLINK cupTHA with MobilLINK TrabecuLINK cup and LCU stem | Device | MobilLINK TrabecuLINK cup |
| Pinnacle Gription cupTHA with Pinnacle Gription cup and Coral stem | Device | Pinnacle Gription Series 100 cup |
Primary outcome
Early migration of the cup
Time frame: 2 years after operation
Migration of the cup between 3 month and 2 years after implantation of the cup measured with Computed Tomography scan based Micromotion Analysis (CTMA) in mm.
13 secondary outcomes
Proximal wear
Time frame: 5 years after operation
3D wear
Time frame: 5 years after operation
Long term migratio
Time frame: 15 years after operation
Long term wear
Time frame: 15 years after operation
Stem migration
Time frame: 15 years
Patient reported outcome with Forgotten Joint Score
Time frame: 15 years after operation
Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score
Time frame: 15 years after operation
Patient reported outcome with University of California, Los Angeles Activity Score
Time frame: 15 years after operation
Patient reported outcome with EuroQuol 5.
Time frame: 15 years after operation
Reoperations
Time frame: 15 years after operation
Osteolysis
Time frame: 15 years after operation
Precision of migration measurements with CTMA
Time frame: 1 year after operation
Precision of wear mearurements with CTMA
Time frame: 1 year after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 29092981Buttaro MA, Onativia JI, Slullitel PA, Andreoli M, Comba F, Zanotti G, Piccaluga F. Metaphyseal debonding of the Corail collarless cementless stem: report of 18 cases and case-control study. Bone Joint J. 2017 Nov;99-B(11):1435-1441. doi: 10.1302/0301-620X.99B11.BJJ-2017-0431.R1.
- Background: PubMed 28778624Louboutin L, Viste A, Desmarchelier R, Fessy MH. Long-term survivorship of the Corail standard stem. Orthop Traumatol Surg Res. 2017 Nov;103(7):987-992. doi: 10.1016/j.otsr.2017.06.010. Epub 2017 Aug 1.
- Background: PubMed 25909455van der Voort P, Pijls BG, Nieuwenhuijse MJ, Jasper J, Fiocco M, Plevier JW, Middeldorp S, Valstar ER, Nelissen RG. Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies. Acta Orthop. 2015;86(5):575-85. doi: 10.3109/17453674.2015.1043832.
- Background: PubMed 18594097Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.
- Background: PubMed 20012862Campbell D, Mercer G, Nilsson KG, Wells V, Field JR, Callary SA. Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study. Int Orthop. 2011 Apr;35(4):483-8. doi: 10.1007/s00264-009-0913-z. Epub 2009 Dec 13.
- Background: PubMed 24269067Goriainov V, Jones A, Briscoe A, New A, Dunlop D. Do the cup surface properties influence the initial stability? J Arthroplasty. 2014 Apr;29(4):757-62. doi: 10.1016/j.arth.2013.07.007. Epub 2013 Nov 22.
- Background: PubMed 23510822Drobniewski M, Borowski A, Synder M, Sibinski M. Results of total cementless hip joint arthroplasty with Corail stem. Ortop Traumatol Rehabil. 2013 Jan-Feb;15(1):61-8. doi: 10.5604/15093492.1032797.
- 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.
Volker Otten, M.D, PhD principal investigator
Umeå University hospital/Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobilLINK TrabecuLINK cup and Pinnacle Gription cup in people with Osteoarthritis, Hip, run by Umeå University at 1 site in Sweden.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2023. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Early migration of the cup (time frame: 2 years after operation). 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 NCT05773261, which also lists 7 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 8 Dec 2023.