Serum Metal Levels, Specifically Cobalt, Chromium, and TitaniumPhase 4NCT03371212
A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA
A Phase 4 study testing Dual mobility cohort and Conventional cohort in people with Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium, run by Rush University Medical Center at 1 site in United States.
Trial summary
The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium
- What is being tested?
- Dual mobility cohort and Conventional cohort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 1 Dec 2036
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Willingness to undergo serial postoperative venipuncture for serum meal analysis
- BMI < 40
- Patients that are eligible for the requisite implants as deemed by their surgeon
Who cannot join
- Clinically significant systemic chronic disease
- Diminished renal function
- Presence of any metal-containing implant outside of the oral cavity
- History of prior hip surgery involving an internal fixation device
- History of hip infection
- Preoperative diagnosis other than osteoarthritis
- Anticipated need for another joint replacement surgery within one year
- Patients taking chromium supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Prospective Randomized Trial of Modular Dual Mobility Acetabular Components Versus Conventional Single Bearing Components in Primary Total Hip Arthroplasty
The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.
Read the detailed description
Prosthetic dislocation following total hip arthroplasty (THA) remains a significant concern with a reported incidence of 0.2%-7.0% after primary and 10%-25% after revision THA. The risk of dislocation following THA is multifactorial and includes both surgeon-related factors (i.e. component positioning, surgical approach) and patient-related factors (i.e. gender, age). Dual mobility articulations have been shown to reduce the incidence of hip instability following THA. Dual mobility implants have been used in Europe for over 30 years, but have recently received an increased interest in the United States.
Initial dual mobility designs consisted of a cementless, monoblock acetabular component with a highly-polished metal inner bearing surface. Modular dual mobility prostheses have been introduced in which a modular cobalt-alloy liner is inserted into a hemispherical titanium acetabular component. Advantages of this construct include familiarity of use of a standard titanium acetabular component and the ability to use supplemental screw fixation. However, the potential for fretting corrosion between the cobalt-alloy liner and the titanium acetabular component remains a concern.
In a retrospective review of 100 consecutive patients undergoing primary THA using a modular dual mobility prosthesis, the authors found 21% of patients to have a serum cobalt level above the normal range, with 9% significantly above normal (> 1.6 ug/L), at a mean of 27.6 months postoperatively. In addition, a recent prospective cohort study of 26 patients receiving the same prosthesis showed elevated whole blood mean cobalt levels in patients receiving a modular dual mobility prosthesis versus patients receiving a conventional bearing (0.23 + 0.39 vs. 0.15 + 0.07ug/L, p<0.001) at 1 year postoperatively. Four patients in the dual mobility cohort had a whole blood cobalt level outside the reference range (maximum 1.81 ug/L).
To the investigators knowledge no prospective, randomized controlled trial has been performed comparing dual mobility bearings to a conventional single-bearing design. Therefore, the purpose of this study is to compare the use of a conventional single-bearing ceramic-on-polyethylene surface to use of a modular dual mobility bearing in a prospective, randomized controlled setting.
- Being tested
- Dual mobility cohort, Conventional cohort
- Keywords
- Dual Mobility, Serum metal levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual mobility cohortDevice
Patients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell.
Conventional cohortDevice
Patients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell
| Study group | Role | What they receive |
|---|---|---|
| Conventional Cohort | Active comparator | Patients in this group will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell. Receives: Device: Conventional cohort |
| Modular Dual Mobility Cohort | Experimental | Patients in this group will receive a Taperloc femoral stem, inner ceramic femoral head (28mm), mobile polyethylene bearing, cobalt alloy liner, and G7 acetabular shell. Receives: Device: Dual mobility cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum chromium levels, measures chromium level in the serum in ug/L
Assays for each subject for serum chromium in ug/L
Measured: up to 5 years
Serum cobalt levels, measures cobalt level in the serum in ug/L
Assays for each subject for serum cobalt in ug/L
Measured: up to 5 years
Serum titanium levels, measures titanium level in the serum in ug/L
Assays for each subject for serum titanium in ug/L
Measured: up to 5 years
Secondary outcomes (5)
Patient reported outcome measures (survey) for SF-12 score.
Subjects will complete the industry common SF-12 survey and total score will be used. Higher scores are better, score of 100 is maximum.
Measured: up to 5 years
Patient reported outcome measures (survey) for the Harris Hip Score
Subjects will complete the industry common Harris Hip survey and total score will be used. Higher scores are better, score of 100 is maximum.
Measured: up to 5 years
Patient reported outcome measures (survey) for the Hoos Jr. score.
Subjects will complete the industry common HOOS Jr. survey and total score will be used. Higher scores are better, score of 100 is maximum.
Measured: up to 5 years
Patient reported outcome measures (survey) for the SANE score.
Subjects will complete the the industry common SANE survey and total score will be used. Higher scores are better, score of 100 is maximum.
Measured: up to 5 years
Patient reported outcome measures (survey) for the UCLA activity score.
Subjects will complete the the industry common UCLA survey and total score will be used. Higher scores are better, score of 100 is maximum.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start15 Dec 2017
- Primary completion1 Dec 2035 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Serum Metal Levels, Specifically Cobalt, Chromium, and TitaniumStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to 1 of 2 treatment groups, which they will be in for the duration of the study. Because of the nature of the study, there will be no crossover.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371212
- Sponsor's protocol ID
- 17060804
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2017
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Patel PD, Potts A, Froimson MI. The dislocating hip arthroplasty: prevention and treatment. J Arthroplasty. 2007 Jun;22(4 Suppl 1):86-90. doi: 10.1016/j.arth.2006.12.111.
PubMed 17570285Berry DJ. Unstable total hip arthroplasty: detailed overview. Instr Course Lect. 2001;50:265-74.
PubMed 11372323Nam D, Salih R, Brown KM, Nunley RM, Barrack RL. Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. J Arthroplasty. 2017 May;32(5):1581-1585. doi: 10.1016/j.arth.2016.12.012. Epub 2016 Dec 21.
PubMed 28057394Haughom BD, Plummer DR, Moric M, Della Valle CJ. Is There a Benefit to Head Size Greater Than 36 mm in Total Hip Arthroplasty? J Arthroplasty. 2016 Jan;31(1):152-5. doi: 10.1016/j.arth.2015.08.011. Epub 2015 Aug 14.
PubMed 26360768Matsen Ko LJ, Pollag KE, Yoo JY, Sharkey PF. Serum Metal Ion Levels Following Total Hip Arthroplasty With Modular Dual Mobility Components. J Arthroplasty. 2016 Jan;31(1):186-9. doi: 10.1016/j.arth.2015.07.035. Epub 2015 Jul 23.
PubMed 26318084Heffernan C, Banerjee S, Nevelos J, Macintyre J, Issa K, Markel DC, Mont MA. Does dual-mobility cup geometry affect posterior horizontal dislocation distance? Clin Orthop Relat Res. 2014 May;472(5):1535-44. doi: 10.1007/s11999-014-3469-1. Epub 2014 Jan 24.
PubMed 24464508Langlais FL, Ropars M, Gaucher F, Musset T, Chaix O. Dual mobility cemented cups have low dislocation rates in THA revisions. Clin Orthop Relat Res. 2008 Feb;466(2):389-95. doi: 10.1007/s11999-007-0047-9. Epub 2008 Jan 10.
PubMed 18196422Loving L, Lee RK, Herrera L, Essner AP, Nevelos JE. Wear performance evaluation of a contemporary dual mobility hip bearing using multiple hip simulator testing conditions. J Arthroplasty. 2013 Jun;28(6):1041-6. doi: 10.1016/j.arth.2012.09.011. Epub 2013 Feb 22.
PubMed 23434106Civinini R, Carulli C, Matassi F, Nistri L, Innocenti M. A dual-mobility cup reduces risk of dislocation in isolated acetabular revisions. Clin Orthop Relat Res. 2012 Dec;470(12):3542-8. doi: 10.1007/s11999-012-2428-y. Epub 2012 Jun 15.
PubMed 22700131Hamadouche M, Arnould H, Bouxin B. Is a cementless dual mobility socket in primary THA a reasonable option? Clin Orthop Relat Res. 2012 Nov;470(11):3048-53. doi: 10.1007/s11999-012-2395-3.
PubMed 22639330Epinette JA, Beracassat R, Tracol P, Pagazani G, Vandenbussche E. Are modern dual mobility cups a valuable option in reducing instability after primary hip arthroplasty, even in younger patients? J Arthroplasty. 2014 Jun;29(6):1323-8. doi: 10.1016/j.arth.2013.12.011. Epub 2013 Dec 16.
PubMed 24444567Plummer DR, Christy JM, Sporer SM, Paprosky WG, Della Valle CJ. Dual-Mobility Articulations for Patients at High Risk for Dislocation. J Arthroplasty. 2016 Sep;31(9 Suppl):131-5. doi: 10.1016/j.arth.2016.03.021. Epub 2016 Mar 17.
PubMed 27101771McArthur BA, Nam D, Cross MB, Westrich GH, Sculco TP. Dual-mobility acetabular components in total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10):473-8.
PubMed 24278908Farizon F, de Lavison R, Azoulai JJ, Bousquet G. Results with a cementless alumina-coated cup with dual mobility. A twelve-year follow-up study. Int Orthop. 1998;22(4):219-24. doi: 10.1007/s002640050246.
PubMed 9795807
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Modular Dual Mobility Acetabular Components Versus Conventional Single Bearing Components in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03371212
- Acronym / sponsor ID
- 17060804
- Keywords
- Dual Mobility, Serum metal levels
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Dec 2035 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 13 Dec 2017 (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.
The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.
Detailed description
Prosthetic dislocation following total hip arthroplasty (THA) remains a significant concern with a reported incidence of 0.2%-7.0% after primary and 10%-25% after revision THA. The risk of dislocation following THA is multifactorial and includes both surgeon-related factors (i.e. component positioning, surgical approach) and patient-related factors (i.e. gender, age). Dual mobility articulations have been shown to reduce the incidence of hip instability following THA. Dual mobility implants have been used in Europe for over 30 years, but have recently received an increased interest in the United States.
Initial dual mobility designs consisted of a cementless, monoblock acetabular component with a highly-polished metal inner bearing surface. Modular dual mobility prostheses have been introduced in which a modular cobalt-alloy liner is inserted into a hemispherical titanium acetabular component. Advantages of this construct include familiarity of use of a standard titanium acetabular component and the ability to use supplemental screw fixation. However, the potential for fretting corrosion between the cobalt-alloy liner and the titanium acetabular component remains a concern.
In a retrospective review of 100 consecutive patients undergoing primary THA using a modular dual mobility prosthesis, the authors found 21% of patients to have a serum cobalt level above the normal range, with 9% significantly above normal (> 1.6 ug/L), at a mean of 27.6 months postoperatively. In addition, a recent prospective cohort study of 26 patients receiving the same prosthesis showed elevated whole blood mean cobalt levels in patients receiving a modular dual mobility prosthesis versus patients receiving a conventional bearing (0.23 + 0.39 vs. 0.15 + 0.07ug/L, p<0.001) at 1 year postoperatively. Four patients in the dual mobility cohort had a whole blood cobalt level outside the reference range (maximum 1.81 ug/L).
To the investigators knowledge no prospective, randomized controlled trial has been performed comparing dual mobility bearings to a conventional single-bearing design. Therefore, the purpose of this study is to compare the use of a conventional single-bearing ceramic-on-polyethylene surface to use of a modular dual mobility bearing in a prospective, randomized controlled setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to 1 of 2 treatment groups, which they will be in for the duration of the study. Because of the nature of the study, there will be no crossover.
| Arm | Type | Receives |
|---|---|---|
| Conventional Cohort | Active comparator | Device: Conventional cohortPatients in this group will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell. |
| Modular Dual Mobility Cohort | Experimental | Device: Dual mobility cohortPatients in this group will receive a Taperloc femoral stem, inner ceramic femoral head (28mm), mobile polyethylene bearing, cobalt alloy liner, and G7 acetabular shell. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Willingness to undergo serial postoperative venipuncture for serum meal analysis
- BMI < 40
- Patients that are eligible for the requisite implants as deemed by their surgeon
Key exclusion criteria (8 listed)
- Clinically significant systemic chronic disease
- Diminished renal function
- Presence of any metal-containing implant outside of the oral cavity
- History of prior hip surgery involving an internal fixation device
- History of hip infection
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 |
|---|---|---|
| Dual mobility cohortPatients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell. | Device | Modular Dual Mobility Cohort |
| Conventional cohortPatients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell | Device | Conventional Cohort |
Primary outcome
Serum chromium levels, measures chromium level in the serum in ug/L
Time frame: up to 5 years
Assays for each subject for serum chromium in ug/L
Serum cobalt levels, measures cobalt level in the serum in ug/L
Time frame: up to 5 years
Assays for each subject for serum cobalt in ug/L
Serum titanium levels, measures titanium level in the serum in ug/L
Time frame: up to 5 years
Assays for each subject for serum titanium in ug/L
5 secondary outcomes
Patient reported outcome measures (survey) for SF-12 score.
Time frame: up to 5 years
Patient reported outcome measures (survey) for the Harris Hip Score
Time frame: up to 5 years
Patient reported outcome measures (survey) for the Hoos Jr. score.
Time frame: up to 5 years
Patient reported outcome measures (survey) for the SANE score.
Time frame: up to 5 years
Patient reported outcome measures (survey) for the UCLA activity score.
Time frame: up to 5 years
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 Jan 2026.
- Background: PubMed 17570285Patel PD, Potts A, Froimson MI. The dislocating hip arthroplasty: prevention and treatment. J Arthroplasty. 2007 Jun;22(4 Suppl 1):86-90. doi: 10.1016/j.arth.2006.12.111.
- Background: PubMed 11372323Berry DJ. Unstable total hip arthroplasty: detailed overview. Instr Course Lect. 2001;50:265-74.
- Background: PubMed 28057394Nam D, Salih R, Brown KM, Nunley RM, Barrack RL. Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. J Arthroplasty. 2017 May;32(5):1581-1585. doi: 10.1016/j.arth.2016.12.012. Epub 2016 Dec 21.
- Background: PubMed 26360768Haughom BD, Plummer DR, Moric M, Della Valle CJ. Is There a Benefit to Head Size Greater Than 36 mm in Total Hip Arthroplasty? J Arthroplasty. 2016 Jan;31(1):152-5. doi: 10.1016/j.arth.2015.08.011. Epub 2015 Aug 14.
- Background: PubMed 26318084Matsen Ko LJ, Pollag KE, Yoo JY, Sharkey PF. Serum Metal Ion Levels Following Total Hip Arthroplasty With Modular Dual Mobility Components. J Arthroplasty. 2016 Jan;31(1):186-9. doi: 10.1016/j.arth.2015.07.035. Epub 2015 Jul 23.
- Background: PubMed 24464508Heffernan C, Banerjee S, Nevelos J, Macintyre J, Issa K, Markel DC, Mont MA. Does dual-mobility cup geometry affect posterior horizontal dislocation distance? Clin Orthop Relat Res. 2014 May;472(5):1535-44. doi: 10.1007/s11999-014-3469-1. Epub 2014 Jan 24.
- Background: PubMed 18196422Langlais FL, Ropars M, Gaucher F, Musset T, Chaix O. Dual mobility cemented cups have low dislocation rates in THA revisions. Clin Orthop Relat Res. 2008 Feb;466(2):389-95. doi: 10.1007/s11999-007-0047-9. Epub 2008 Jan 10.
- Background: PubMed 23434106Loving L, Lee RK, Herrera L, Essner AP, Nevelos JE. Wear performance evaluation of a contemporary dual mobility hip bearing using multiple hip simulator testing conditions. J Arthroplasty. 2013 Jun;28(6):1041-6. doi: 10.1016/j.arth.2012.09.011. Epub 2013 Feb 22.
- Background: PubMed 22700131Civinini R, Carulli C, Matassi F, Nistri L, Innocenti M. A dual-mobility cup reduces risk of dislocation in isolated acetabular revisions. Clin Orthop Relat Res. 2012 Dec;470(12):3542-8. doi: 10.1007/s11999-012-2428-y. Epub 2012 Jun 15.
- Background: PubMed 22639330Hamadouche M, Arnould H, Bouxin B. Is a cementless dual mobility socket in primary THA a reasonable option? Clin Orthop Relat Res. 2012 Nov;470(11):3048-53. doi: 10.1007/s11999-012-2395-3.
- Background: PubMed 24444567Epinette JA, Beracassat R, Tracol P, Pagazani G, Vandenbussche E. Are modern dual mobility cups a valuable option in reducing instability after primary hip arthroplasty, even in younger patients? J Arthroplasty. 2014 Jun;29(6):1323-8. doi: 10.1016/j.arth.2013.12.011. Epub 2013 Dec 16.
- Background: PubMed 27101771Plummer DR, Christy JM, Sporer SM, Paprosky WG, Della Valle CJ. Dual-Mobility Articulations for Patients at High Risk for Dislocation. J Arthroplasty. 2016 Sep;31(9 Suppl):131-5. doi: 10.1016/j.arth.2016.03.021. Epub 2016 Mar 17.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual mobility cohort and Conventional cohort in people with Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium, run by Rush University Medical Center at 1 site in United States.
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 8 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 Jan 2026. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum chromium levels, measures chromium level in the serum in ug/L (time frame: up to 5 years). The study lists 3 primary outcomes in all. 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 NCT03371212, which also lists 14 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 Jan 2026.