SPINAL FractureA34RCTNCT05769114
Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture
A study testing Surgical stabilization in people with SPINAL Fracture and Burst Fracture, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SPINAL Fracture, Burst Fracture, Spinal Instability of Thoracolumbar Region
- What is being tested?
- Surgical stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Apr 2023to Mar 2030
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years at inclusion
- Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
- Informed consent for study participation
Who cannot join
- Injury of the posterior tension band/posterior column of the thoracolumbar spine
- Any neurological deficit (American Spinal Injury Association Impairment Scale [AISA] Grade A-D)
- Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- Multiple trauma or Injury Severity Score (ISS) > 16 or additional injuries according to the investigator may, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study (impairment of early ambulation)
- Any known previous spinal surgery in the thoracolumbar spine, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
Show all 10Show fewer
- Any severe, progressive, or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study
- Known history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment in the opinion of the investigator
- Pregnancy or women planning to conceive within the study period. All women included in this study must have a negative blood pregnancy test (human chorionic gonadotrophin (hCG) blood level at visit 1. If pregnancy occurs during the study period, the patients drop out of the study
- Inability to follow the procedures of the study, e.g., due to inability to understand German, French or English, which, according to the investigator, may jeopardize the patient in case of participation in the study or prevents the patient from participating in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital
Bern, 3010
Sonja Häckel, MD, +41 (0) 31 664 15 50, Sonja.haeckel@insel.ch
Veronique Jungo, veronique.jungo@insel.ch
- Not yet recruiting
Ostschweizer Wirbelsaeulenzentrum Kantonsspital St. Gallen
Sankt Gallen, 9007
Martin Stienen, Prof. Dr., +41 71 494 77 77, wirbelsaeulenzentrum@h-och.ch
About this study
Official title: Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms.
The study's precise objectives are to:
- evaluate the clinical outcome (Oswestry Disability Index)
- evaluate the radiography result (restoration and maintenance of spinal alignment)
- determine the prevalence of complications at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.
Read the detailed description
The research is a single-center, nationwide, randomized controlled trial. Over a two-year period, 52 patients with a thoracolumbar burst fracture will enroll in the study. They will be assigned randomly (1:1) to either non-surgical treatment with a brace or surgery with anterior-posterior fixation. A prospective data collection will be asked of subjects who decline randomization (observational arm). The subjects will be evaluated clinically, radiologically, and based on patient-reported outcomes over the course of two years. Both patient files and questionnaires will be used to collect data.
- Being tested
- Surgical stabilization
- Keywords
- Traumatic Thoracolumbar Spine Burst Fracture
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical stabilizationProcedure or surgery
Also called 360°-Stabilization
Anterior-posterior stabilization (360°) with pedicle screws and an expandable cage
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Active comparator | The surgeon will perform a minimally invasive (percutaneous) posterior stabilization of the injured spinal segments. Transpedicular screws will be inserted into the vertebral body superior and inferior to the fractured vertebra under fluoroscopic control. In a second stage procedure a lumbo- or thoracotomy (depending on the fracture level below or above the diaphragm) is performed to remove the fractured part of the vertebral body (hemicorporectomy) including the intervertebral disc segments. The resulting void is replaced by an (expandable) spacer/cage. Receives: Procedure: Surgical stabilization |
| Non-surgical treatment | No intervention | The patients will receive an external bracing (3-point hyperextension brace) for six weeks, which must be always worn except when lying flat in bed. The brace is adjusted by an experienced orthopedist. A physiotherapist will instruct the patient to accomplish daily activities with the restriction he or she will have by wearing the brace. |
| Observational arm | Other | Patients who do not agree to randomization will be given the option to participate in the observational arm of the study. Their treatment will be surgical fixation with an anterior-posterior stabilization (as per our current internal hospital standard). Receives: Procedure: Surgical stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
Measured: 2 years after fracture
Secondary outcomes (17)
Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle
Bi-/segmental kyphosis (Gardner/Cobb angle) assessed by long-standing x-rays of the entire spine
Measured: Pre-Treatment to 2 years after the fracture
Radiological outcome: Spinal fusion and fracture consolidation
Spinal fusion in the surgical group and fracture consolidation in the non-surgical group assessed by CT-scan
Measured: 26 weeks after fracture
Radiological outcome: Segment mobility
Segment mobility assessed by functional lateral views at 52 weeks and compared between treatment groups
Measured: 52 weeks after fracture
Radiological outcome: Degeneration of the intervertebral disc over time
Degeneration of the intervertebral disc (Pfirrmann grade)
Measured: Pre-Treatment, 52 weeks after the fracture
Radiological outcome: Progression of spinal canal stenosis
Assessed on CT-scan and MRI
Measured: From the time of fracture, 26 weeks and 52 weeks
Non-surgical treatment failure rate
Proportion/frequency of patients in the non-surgery group that received surgery later, if there is a clinical indication (spinal instability measured by a kyphosis > 30 degrees on x-ray, intolerable pain, delayed onset of neurological symptoms) or if the patient is not satisfied after treatment
Measured: From the time of fracture to 2 years after the fracture
Complication rate and severity and additional surgeries
Rate and severity according to the Spine Adverse Events Severity System (SAVES) and surgical complications between treatment groups
Measured: 6, 12, 26, 52, and 104 weeks
Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST)
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Measured: From the time of fracture to 2 years after the fracture
Changes in patient-related outcome measurements: EQ5D-3L
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Measured: Pre-Treatment to 2 years after the fracture
Changes in patient-related outcome measurements: Pain visual analogue scale (VAS)
Changes between groups and from baseline to follow-up 104 weeks and compared between treatment groups
Measured: Pre-Treatment to 2 years after the fracture
Indirect costs
Assessed by indirect cost questionnaire and compared between treatment groups
Measured: 6, 12, 26, 52, and 104 weeks
Treatment data: Length of hospitalization (days)
Inhospital data records, comparison between treatment groups
Measured: Pre-Treatment to discharge from hospital
Treatment data: blood loss during surgery (ml)
Inhospital data records
Measured: during surgery
Treatment data: duration of surgery (hh: mm)
Inhospital data records
Measured: during surgery
Time to return to work/sports
Documented at each clinical follow-up as internal clinic standard of care, comparison between treatment groups
Measured: 6, 12, 26, 52, and 104 weeks
Radiological outcome: Sagittal and coronal alignment
Assessed by long-standing x-rays of the entire spine, comparison between treatment groups
Measured: 6, 12, 26, 52, and 104 weeks
Opioid use
Use of oral intake of opioids, comparison between treatment groups and changes from baseline to 104 weeks
Measured: Pre-Treatment, 6, 12, 26, 52, and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start18 Apr 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Christoph E Albers, PD Dr., Principal investigator, Inselspital Bern, Department of Orthopaedic Surgery and TraumatologySonja Häckel, Dr., Study director, Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769114
- Sponsor's protocol ID
- 2022-00662
- Acronym
- A34RCT
- Status last verified
- May 2026
- First submitted
- 8 Feb 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No process has been defined yet how the sharing of the data should proceed
Publications
Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5.
PubMed 22057820Vaccaro AR, Oner C, Kepler CK, Dvorak M, Schnake K, Bellabarba C, Reinhold M, Aarabi B, Kandziora F, Chapman J, Shanmuganathan R, Fehlings M, Vialle L; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013 Nov 1;38(23):2028-37. doi: 10.1097/BRS.0b013e3182a8a381.
PubMed 23970107Oner FC, Wood KB, Smith JS, Shaffrey CI. Therapeutic decision making in thoracolumbar spine trauma. Spine (Phila Pa 1976). 2010 Oct 1;35(21 Suppl):S235-44. doi: 10.1097/BRS.0b013e3181f32734.
PubMed 20881467Spiegl UJ, Fischer K, Schmidt J, Schnoor J, Delank S, Josten C, Schulte T, Heyde CE. The Conservative Treatment of Traumatic Thoracolumbar Vertebral Fractures. Dtsch Arztebl Int. 2018 Oct 19;115(42):697-704. doi: 10.3238/arztebl.2018.0697.
PubMed 30479250
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Surgical Versus Primary Non-Surgical Treatment of Traumatic Thoracolumbar Spine Burst Fracture in Patients Without Neurological Symptoms: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05769114
- Acronym / sponsor ID
- A34RCT / 2022-00662
- Keywords
- Traumatic Thoracolumbar Spine Burst Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 15 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.
Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms.
The study's precise objectives are to:
- evaluate the clinical outcome (Oswestry Disability Index)
- evaluate the radiography result (restoration and maintenance of spinal alignment)
- determine the prevalence of complications at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.
Detailed description
The research is a single-center, nationwide, randomized controlled trial. Over a two-year period, 52 patients with a thoracolumbar burst fracture will enroll in the study. They will be assigned randomly (1:1) to either non-surgical treatment with a brace or surgery with anterior-posterior fixation. A prospective data collection will be asked of subjects who decline randomization (observational arm). The subjects will be evaluated clinically, radiologically, and based on patient-reported outcomes over the course of two years. Both patient files and questionnaires will be used to collect data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: Surgical stabilizationThe surgeon will perform a minimally invasive (percutaneous) posterior stabilization of the injured spinal segments. Transpedicular screws will be inserted into the vertebral body superior and inferior to the fractured vertebra under fluoroscopic control. In a second stage procedure a lumbo- or thoracotomy (depending on the fracture level below or above the diaphragm) is performed to remove the fractured part of the vertebral body (hemicorporectomy) including the intervertebral disc segments. The resulting void is replaced by an (expandable) spacer/cage. |
| Non-surgical treatment | No intervention | –The patients will receive an external bracing (3-point hyperextension brace) for six weeks, which must be always worn except when lying flat in bed. The brace is adjusted by an experienced orthopedist. A physiotherapist will instruct the patient to accomplish daily activities with the restriction he or she will have by wearing the brace. |
| Observational arm | Other | Procedure: Surgical stabilizationPatients who do not agree to randomization will be given the option to participate in the observational arm of the study. Their treatment will be surgical fixation with an anterior-posterior stabilization (as per our current internal hospital standard). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 70 years at inclusion
- Acute traumatic burst fracture of the thoracolumbar spine (10th thoracic to 3rd lumbar vertebral body)
- Informed consent for study participation
Key exclusion criteria (10 listed)
- Injury of the posterior tension band/posterior column of the thoracolumbar spine
- Any neurological deficit (American Spinal Injury Association Impairment Scale [AISA] Grade A-D)
- Pathological vertebral body fractures (diagnosed by MRI and CT scan), which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- Concomitant spinal fractures at any other level of the spine outside the T10-L3 level, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study
- Multiple trauma or Injury Severity Score (ISS) > 16 or additional injuries according to the investigator may, which, in the opinion of the research/investigative team, would compromise (or interfere with) patients' ability to participate in the study (impairment of early ambulation)
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 |
|---|---|---|
| Surgical stabilizationAlso: 360°-StabilizationAnterior-posterior stabilization (360°) with pedicle screws and an expandable cage | Procedure or surgery | Observational arm, Surgical treatment |
Primary outcome
The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation
Time frame: 2 years after fracture
ODI is a patient-reported outcome measure for spinal disorders. It consists of 10 questions related to back specific disabilities such as pain, personal care, walking and sitting ability, lifting capacity and social life.
17 secondary outcomes
Radiological outcome: Mono- (A3-fractures)/Bisegmental (A4-fractures) kyphosis angle
Time frame: Pre-Treatment to 2 years after the fracture
Radiological outcome: Spinal fusion and fracture consolidation
Time frame: 26 weeks after fracture
Radiological outcome: Segment mobility
Time frame: 52 weeks after fracture
Radiological outcome: Degeneration of the intervertebral disc over time
Time frame: Pre-Treatment, 52 weeks after the fracture
Radiological outcome: Progression of spinal canal stenosis
Time frame: From the time of fracture, 26 weeks and 52 weeks
Non-surgical treatment failure rate
Time frame: From the time of fracture to 2 years after the fracture
Complication rate and severity and additional surgeries
Time frame: 6, 12, 26, 52, and 104 weeks
Changes in patient-related outcome measurements: AOSpine Patient Reported Outcome Spine Trauma (PROST)
Time frame: From the time of fracture to 2 years after the fracture
Changes in patient-related outcome measurements: EQ5D-3L
Time frame: Pre-Treatment to 2 years after the fracture
Changes in patient-related outcome measurements: Pain visual analogue scale (VAS)
Time frame: Pre-Treatment to 2 years after the fracture
Indirect costs
Time frame: 6, 12, 26, 52, and 104 weeks
Treatment data: Length of hospitalization (days)
Time frame: Pre-Treatment to discharge from hospital
Treatment data: blood loss during surgery (ml)
Time frame: during surgery
Treatment data: duration of surgery (hh: mm)
Time frame: during surgery
Time to return to work/sports
Time frame: 6, 12, 26, 52, and 104 weeks
Radiological outcome: Sagittal and coronal alignment
Time frame: 6, 12, 26, 52, and 104 weeks
Opioid use
Time frame: Pre-Treatment, 6, 12, 26, 52, and 104 weeks
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 7 May 2026.
- Background: PubMed 22057820Gnanenthiran SR, Adie S, Harris IA. Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis. Clin Orthop Relat Res. 2012 Feb;470(2):567-77. doi: 10.1007/s11999-011-2157-7. Epub 2011 Nov 5.
- Background: PubMed 23970107Vaccaro AR, Oner C, Kepler CK, Dvorak M, Schnake K, Bellabarba C, Reinhold M, Aarabi B, Kandziora F, Chapman J, Shanmuganathan R, Fehlings M, Vialle L; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013 Nov 1;38(23):2028-37. doi: 10.1097/BRS.0b013e3182a8a381.
- Background: PubMed 20881467Oner FC, Wood KB, Smith JS, Shaffrey CI. Therapeutic decision making in thoracolumbar spine trauma. Spine (Phila Pa 1976). 2010 Oct 1;35(21 Suppl):S235-44. doi: 10.1097/BRS.0b013e3181f32734.
- Background: PubMed 30479250Spiegl UJ, Fischer K, Schmidt J, Schnoor J, Delank S, Josten C, Schulte T, Heyde CE. The Conservative Treatment of Traumatic Thoracolumbar Vertebral Fractures. Dtsch Arztebl Int. 2018 Oct 19;115(42):697-704. doi: 10.3238/arztebl.2018.0697.
- Individual participant dataSharing planned: No. No process has been defined yet how the sharing of the data should proceed
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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.
Christoph E Albers, PD Dr. principal investigator
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
Sonja Häckel, Dr. study director
Inselspital Bern, Department of Orthopaedic Surgery and Traumatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical stabilization in people with SPINAL Fracture and Burst Fracture, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Contact Christoph E Albers, PD Dr. (+41 (0) 31 664 04 40, christoph.albers@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical outcome as assessed by the Oswestry Disability Index (ODI) 104 weeks post-surgery or non-surgical treatment initiation (time frame: 2 years after fracture). 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 NCT05769114, which also lists 4 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 7 May 2026.