Acute Disruption of Ankle SyndesmosisNCT04972578
Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
A study testing Suture Button vs Screw Fixation in people with Acute Disruption of Ankle Syndesmosis, run by University of Nebraska at 3 sites in United States.
Trial summary
Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Disruption of Ankle Syndesmosis
- What is being tested?
- Suture Button vs Screw Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2021to 9 Jan 2026
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years of age and older
- Isolated rotational ankle injury
- Syndesmotic instability (determined either pre- or intra-operatively)
- Length-stable fibula fracture pattern
Who cannot join
- Open fracture
- Length-unstable fracture pattern (including Maisonneuve fracture pattern)
- Syndesmotic stability (determined either pre- or intra-operatively)
- Lower extremity neuropathy
- History of prior trauma or surgery to injured ankle
- Non-ambulatory
- Use of ambulatory assistive device prior to injury
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nebraska Medicine, Bellevue Health Center
Bellevue, Nebraska, 68123
Lauritzen Outpatient Center
Omaha, Nebraska, 68105
Village Point Outpatient Center
Omaha, Nebraska, 68118
About this study
Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.
Read the detailed description
This will be a prospective randomized study. Patients with isolated rotational ankle injuries with syndesmotic instability will be randomized to either screw fixation or suture fixation for treatment of their syndesmotic injury. Patients will be followed postoperatively for one year following surgery with documentation of both clinical outcomes and subjective patient reported outcomes. Additionally, postoperative gait patterns will be measured and compared between patients who had syndesmotic injuries treated with screw fixation versus suture fixation
- Conditions
- Acute Disruption of Ankle Syndesmosis
- Being tested
- Suture Button vs Screw Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture Button vs Screw FixationDevice
Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)
| Study group | Role | What they receive |
|---|---|---|
| Screw Fixation | Active comparator | Traditional fixation method of placing one or two screws across the syndesmosis. Receives: Device: Suture Button vs Screw Fixation |
| Suture Button | Active comparator | Suture button implants which use a suture and anchor to repair the syndesmosis Receives: Device: Suture Button vs Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameter - Step length
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Step length
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Step length
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Gait parameter - Step width
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Step width
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Step width
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 Year
Gait parameter - Step time
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Step time
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Step time
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Gait parameter - Swing time
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Swing time
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Swing time
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Gait parameter - Stance time
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Stance time
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Stance time
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Gait parameter - Double support time
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Double support time
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Double support time
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Gait parameter - Gait speed
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 3 months
Gait parameter - Gait speed
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 6 months
Gait parameter - Gait speed
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Measured: 1 year
Secondary outcomes (9)
Time to fracture union
Time to fracture union will be obtained based upon radiographic analysis at routine clinical follow-up visits.
Measured: 6 weeks, 3 months, 6 months, and 1 year
Maintenance of syndesmotic reduction
Maintenance or loss of syndesmotic reduction will be evaluated radiographically at routine clinical follow-up visits.
Measured: 6 weeks, 3 months, 6 months, and 1 year
Development of radiographic arthritis
Presence or absence of new radiographic tibiotalar arthritis will be noted on radiographs obtained at routine clinical follow-up visits.
Measured: 6 weeks, 3 months, 6 months, and 1 year
Implant complications
Presence or absence of implant-related complications will be assessed radiographically at routine clinical follow-up visits (defined as screw fracture, loss of fixation, osteolysis surrounding implant).
Measured: 6 weeks, 3 months, 6 months, and 1 year
Secondary procedures
The need for secondary procedures will be recorded. Secondary procedures would include of return trips to the OR for infection, for implant removal, for revision reduction or fixation, as well as in-office procedures including implant removal
Measured: 1 year
Postoperative wound complications
Presence or absence of wound complications will be evaluated on physical exam at routine clinical follow-up visits (defined as superficial or deep infection, delayed wound healing, wound dehiscence).
Measured: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Ankle range of motion
Ankle range of motion (tibiotalar dorsiflexion and plantarflexion) will be evaluated on physical exam at routine clinical follow-up visits (measured in degrees of dorsiflexion or plantarflexion from neutral).
Measured: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity)
The PROMIS LE is a computer-adaptive test that reports a score of patient-perceived physical functioning (walking and mobility) specific to the lower extremity. Scores are reported as T scores, with a score of 50 equal to the mean of the general population. Higher scores indicate more favorable physical function. Theoretical maximum and minimum scores are 100 and 0, respectively.
Measured: 3 months, 6 months, and 1 year
Patient reported outcomes - Olerud-Molander Score
The Olerud-Molander Score was designed to score patient-reported outcomes regarding symptoms after ankle fracture. Scale minimum and maximum are 0 and 100, respectively, with a higher score indicative of improved outcome.
Measured: 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Oct 2021
- Primary completion8 Jan 2026
- Study completion9 Jan 2026
Why it stopped: Follow-up and consent was difficult and accrual was not being met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Disruption of Ankle SyndesmosisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah M Putnam, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972578
- Sponsor's protocol ID
- 0146-21-FB
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
- ClinicalTrials.gov ID
- NCT04972578
- Acronym / sponsor ID
- 0146-21-FB
- Conditions
- Acute Disruption of Ankle Syndesmosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Follow-up and consent was difficult and accrual was not being met.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.
Detailed description
This will be a prospective randomized study. Patients with isolated rotational ankle injuries with syndesmotic instability will be randomized to either screw fixation or suture fixation for treatment of their syndesmotic injury. Patients will be followed postoperatively for one year following surgery with documentation of both clinical outcomes and subjective patient reported outcomes. Additionally, postoperative gait patterns will be measured and compared between patients who had syndesmotic injuries treated with screw fixation versus suture fixation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screw Fixation | Active comparator | Device: Suture Button vs Screw FixationTraditional fixation method of placing one or two screws across the syndesmosis. |
| Suture Button | Active comparator | Device: Suture Button vs Screw FixationSuture button implants which use a suture and anchor to repair the syndesmosis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years of age and older
- Isolated rotational ankle injury
- Syndesmotic instability (determined either pre- or intra-operatively)
- Length-stable fibula fracture pattern
Key exclusion criteria (7 listed)
- Open fracture
- Length-unstable fracture pattern (including Maisonneuve fracture pattern)
- Syndesmotic stability (determined either pre- or intra-operatively)
- Lower extremity neuropathy
- History of prior trauma or surgery to injured ankle
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 |
|---|---|---|
| Suture Button vs Screw FixationSyndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis) | Device | Screw Fixation, Suture Button |
Primary outcome
Gait parameter - Step length
Time frame: 3 months
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step length
Time frame: 6 months
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step length
Time frame: 1 year
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
Time frame: 3 months
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
Time frame: 6 months
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
Time frame: 1 Year
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
Time frame: 3 months
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
Time frame: 6 months
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
Time frame: 1 year
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
Time frame: 3 months
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
Time frame: 6 months
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
Time frame: 1 year
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Stance time
Time frame: 3 months
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Stance time
Time frame: 6 months
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Stance time
Time frame: 1 year
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
Time frame: 3 months
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
Time frame: 6 months
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
Time frame: 1 year
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
Time frame: 3 months
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
Time frame: 6 months
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
Time frame: 1 year
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
9 secondary outcomes
Time to fracture union
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Maintenance of syndesmotic reduction
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Development of radiographic arthritis
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Implant complications
Time frame: 6 weeks, 3 months, 6 months, and 1 year
Secondary procedures
Time frame: 1 year
Postoperative wound complications
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Ankle range of motion
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity)
Time frame: 3 months, 6 months, and 1 year
Patient reported outcomes - Olerud-Molander Score
Time frame: 3 months, 6 months, and 1 year
Results and safety
The study was stopped early (reason given: Follow-up and consent was difficult and accrual was not being met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- 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.
Sarah M Putnam, MD principal investigator
University of Nebraska
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture Button vs Screw Fixation in people with Acute Disruption of Ankle Syndesmosis, run by University of Nebraska at 3 sites 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 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: stopped early, as of the sponsor's last update on 13 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 3 sites 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.
Are results available for this study?
The study was stopped early (reason given: Follow-up and consent was difficult and accrual was not being met.). Results are not available in the source record.
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?
Gait parameter - Step length (time frame: 3 months). The study lists 21 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 13 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.