OsteoporosisPSFOLSNCT04399421
Pedicle Screw Fixation in Osteoporotic Lumbar Spine
An observational study of Osteoporosis and Degenerative Lumbar Diseases, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Degenerative Lumbar Diseases
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2021to 31 Dec 2024
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the orthopaedic department of the Peking University Third Hospital, the osteoporotic in-patients requiring lumbar pedicle screw fixation for lumbar degenerative diseases are invited to participate in the study.
Who may be able to join
- aged≥ 50 years old
- lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis and etc.
- no response to nonoperative treatment of at least 3 months
- osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCT, or vertebral Hounsfield units
- informed consent
Who cannot join
- no lumbar CT scans within 3 months before the surgery
- no dual energy x-ray absorptiometry within 6 months before the surgery
- history of lumbar fusion surgery
- cervical myelopathy, thoracic spinal stenosis, motor neuron disease, tuberculosis of spine, spinal tumor
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Pedicle Screw Fixation in Osteoporotic Patients With Degenerative Lumbar Diseases: a Prospective Cohort Study
This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. This study mainly focuses on the most common osteoporosis-related surgical complications, which are pedicle screw loosening and the failure of lumbar fusion. The global and local bone mineral density(BMD) are evaluated with DXA, vertebral CT Hounsfield units(HU) before the surgery. The mechanical strength of the bone mass within the screw trajectory is also measured with a customized device during the surgery. We explored the effect of BMD on the pedicle screw loosening rate and fusion rate. In addition, the patients undergoing lumbar fixation with conventional pedicle screws without the use of bone cement are compared with those undergoing the fixation augmented with bone cement. The objective is to offer more detailed clinical evidence to guide the use of pedicle screw augmentation techniques in osteoporotic patients.
Read the detailed description
Pedicle screw fixation is a widely used technique for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine before solid fusion and restore spinal balance. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the pedicle screw loosening has become a frequently reported complication. The bone-screw interface in osteoporotic spine is unstable, leading to reduced pull-out force and cut-out force.
Previous studies have widely reported the bone cement augmentation techniques used to directly strengthen the pedicle screws. It has been proved that cement-augmented pedicle screw fixation is associated with lower loosening rate and higher fusion rate. However, the use of cement can lead to cement leakage and pulmonary embolism, and need extra cost. Therefore, it is very important to identify the correlation between degree of osteoporosis and screw loosening risk , and to establish the indications for cement augmentation in osteoporotic patients.
The osteoporotic patients requiring posterior lumbar fusion with pedicle screw fixation are prospectively enrolled and followed up. The researchers will invite appropriate patients to participate in the study after their surgical plans are determined. General patients data are collected after informed consent, such as age, gender, weight, height, bone mineral density measured in T-scores and Hounsfield units, the mechanical strength of the bone mass within the screw trajectory, detailed surgical plans, and etc. They are followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar x-ray and certain questions about the clinical outcomes. In addition, this study requires the patients to have lumbar CT scans because its advantage in judging the fusion status. In addition, the ODI and VAS scores are also routinely recorded.
The patients undergoing conventional pedicle screw fixation without cement augmentation are compared with those undergoing the fixation augmented with bone cement. The primary endpoints are the loosening rate and fusion rate at 12 months follow-up. The secondary endpoints are the loosening rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI and VAS) at every follow-up. We also explored the correlation between the BMD information measured with different methods and the patients outcomes, in order to find the high-risk patient group.
- Conditions
- Osteoporosis, Degenerative Lumbar Diseases
- Keywords
- Osteoporosis, Pedicle screw fixation, Degenerative lumbar diseases
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional pedicle screw fixation | Patients undergoing conventional pedicle screw fixation without the use of bone cement. | |
| Cement-augmented pedicle screw fixation | Patients undergoing pedicle screw fixation augmented with bone cement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedicle screw loosening
The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images
Measured: 12 months
Lumbar fusion
The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.
Measured: 12 months
Secondary outcomes (5)
Pedicle screw loosening
The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images
Measured: 3 months; 6 months; 24 months
Lumbar fusion
The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.
Measured: 3 months; 6 months; 24 months
The Oswestry Disability Index（ODI）
The Oswestry Disability Index (ODI) (%，0-100) is used to assess disability.
Measured: 3 months; 12 months; 6 months; 24 months
VAS score for low back pain
The Visual Analog Scale (VAS 0-10) is used the evaluate low back pain.
Measured: 3 months; 12 months; 6 months; 24 months
VAS score for leg pain
The Visual Analog Scale (VAS 0-10) is used the evaluate leg pain.
Measured: 3 months; 12 months; 6 months; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start3 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weishi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399421
- Sponsor's protocol ID
- BYSYDL2019006
- Acronym
- PSFOLS
- Status last verified
- Jul 2022
- First submitted
- 19 May 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the clinical study report available half a year after the publication of the results of the study.
Publications
Pannell WC, Savin DD, Scott TP, Wang JC, Daubs MD. Trends in the surgical treatment of lumbar spine disease in the United States. Spine J. 2015 Aug 1;15(8):1719-27. doi: 10.1016/j.spinee.2013.10.014. Epub 2013 Oct 31.
PubMed 24184652Amirouche F, Solitro GF, Magnan BP. Stability and Spine Pedicle Screws Fixation Strength-A Comparative Study of Bone Density and Insertion Angle. Spine Deform. 2016 Jul;4(4):261-267. doi: 10.1016/j.jspd.2015.12.008. Epub 2016 Jun 16.
PubMed 27927514Okuyama K, Abe E, Suzuki T, Tamura Y, Chiba M, Sato K. Influence of bone mineral density on pedicle screw fixation: a study of pedicle screw fixation augmenting posterior lumbar interbody fusion in elderly patients. Spine J. 2001 Nov-Dec;1(6):402-7. doi: 10.1016/s1529-9430(01)00078-x.
PubMed 14588296Bredow J, Boese CK, Werner CM, Siewe J, Lohrer L, Zarghooni K, Eysel P, Scheyerer MJ. Predictive validity of preoperative CT scans and the risk of pedicle screw loosening in spinal surgery. Arch Orthop Trauma Surg. 2016 Aug;136(8):1063-7. doi: 10.1007/s00402-016-2487-8. Epub 2016 Jun 16.
PubMed 27312862Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication? Eur Spine J. 2015 May;24(5):1005-16. doi: 10.1007/s00586-015-3768-6. Epub 2015 Jan 24.
PubMed 25616349Tokuhashi Y, Matsuzaki H, Oda H, Uei H. Clinical course and significance of the clear zone around the pedicle screws in the lumbar degenerative disease. Spine (Phila Pa 1976). 2008 Apr 15;33(8):903-8. doi: 10.1097/BRS.0b013e31816b1eff.
PubMed 18404111Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.
PubMed 26378363Janssen I, Ryang YM, Gempt J, Bette S, Gerhardt J, Kirschke JS, Meyer B. Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine. Spine J. 2017 Jun;17(6):837-844. doi: 10.1016/j.spinee.2017.01.009. Epub 2017 Jan 17.
PubMed 28108403Zou D, Muheremu A, Sun Z, Zhong W, Jiang S, Li W. Computed tomography Hounsfield unit-based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. J Neurosurg Spine. 2020 Jan 3;32(5):716-721. doi: 10.3171/2019.11.SPINE19868. Print 2020 May 1.
PubMed 31899883Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.
PubMed 31725127Zou D, Li W, Deng C, Du G, Xu N. The use of CT Hounsfield unit values to identify the undiagnosed spinal osteoporosis in patients with lumbar degenerative diseases. Eur Spine J. 2019 Aug;28(8):1758-1766. doi: 10.1007/s00586-018-5776-9. Epub 2018 Oct 10.
PubMed 30306332
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedicle Screw Fixation in Osteoporotic Patients With Degenerative Lumbar Diseases: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04399421
- Acronym / sponsor ID
- PSFOLS / BYSYDL2019006
- Conditions
- Osteoporosis, Degenerative Lumbar Diseases
- Keywords
- Osteoporosis, Pedicle screw fixation, Degenerative lumbar diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2020 (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.
This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. This study mainly focuses on the most common osteoporosis-related surgical complications, which are pedicle screw loosening and the failure of lumbar fusion. The global and local bone mineral density(BMD) are evaluated with DXA, vertebral CT Hounsfield units(HU) before the surgery. The mechanical strength of the bone mass within the screw trajectory is also measured with a customized device during the surgery. We explored the effect of BMD on the pedicle screw loosening rate and fusion rate. In addition, the patients undergoing lumbar fixation with conventional pedicle screws without the use of bone cement are compared with those undergoing the fixation augmented with bone cement. The objective is to offer more detailed clinical evidence to guide the use of pedicle screw augmentation techniques in osteoporotic patients.
Detailed description
Pedicle screw fixation is a widely used technique for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine before solid fusion and restore spinal balance. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the pedicle screw loosening has become a frequently reported complication. The bone-screw interface in osteoporotic spine is unstable, leading to reduced pull-out force and cut-out force.
Previous studies have widely reported the bone cement augmentation techniques used to directly strengthen the pedicle screws. It has been proved that cement-augmented pedicle screw fixation is associated with lower loosening rate and higher fusion rate. However, the use of cement can lead to cement leakage and pulmonary embolism, and need extra cost. Therefore, it is very important to identify the correlation between degree of osteoporosis and screw loosening risk , and to establish the indications for cement augmentation in osteoporotic patients.
The osteoporotic patients requiring posterior lumbar fusion with pedicle screw fixation are prospectively enrolled and followed up. The researchers will invite appropriate patients to participate in the study after their surgical plans are determined. General patients data are collected after informed consent, such as age, gender, weight, height, bone mineral density measured in T-scores and Hounsfield units, the mechanical strength of the bone mass within the screw trajectory, detailed surgical plans, and etc. They are followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar x-ray and certain questions about the clinical outcomes. In addition, this study requires the patients to have lumbar CT scans because its advantage in judging the fusion status. In addition, the ODI and VAS scores are also routinely recorded.
The patients undergoing conventional pedicle screw fixation without cement augmentation are compared with those undergoing the fixation augmented with bone cement. The primary endpoints are the loosening rate and fusion rate at 12 months follow-up. The secondary endpoints are the loosening rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI and VAS) at every follow-up. We also explored the correlation between the BMD information measured with different methods and the patients outcomes, in order to find the high-risk patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional pedicle screw fixation | – | –Patients undergoing conventional pedicle screw fixation without the use of bone cement. |
| Cement-augmented pedicle screw fixation | – | –Patients undergoing pedicle screw fixation augmented with bone cement. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the orthopaedic department of the Peking University Third Hospital, the osteoporotic in-patients requiring lumbar pedicle screw fixation for lumbar degenerative diseases are invited to participate in the study.
Key inclusion criteria (5 listed)
- aged≥ 50 years old
- lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis and etc.
- no response to nonoperative treatment of at least 3 months
- osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCT, or vertebral Hounsfield units
- informed consent
Key exclusion criteria (4 listed)
- no lumbar CT scans within 3 months before the surgery
- no dual energy x-ray absorptiometry within 6 months before the surgery
- history of lumbar fusion surgery
- cervical myelopathy, thoracic spinal stenosis, motor neuron disease, tuberculosis of spine, spinal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pedicle screw loosening
Time frame: 12 months
The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images
Lumbar fusion
Time frame: 12 months
The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.
5 secondary outcomes
Pedicle screw loosening
Time frame: 3 months; 6 months; 24 months
Lumbar fusion
Time frame: 3 months; 6 months; 24 months
The Oswestry Disability Index（ODI）
Time frame: 3 months; 12 months; 6 months; 24 months
VAS score for low back pain
Time frame: 3 months; 12 months; 6 months; 24 months
VAS score for leg pain
Time frame: 3 months; 12 months; 6 months; 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 24184652Pannell WC, Savin DD, Scott TP, Wang JC, Daubs MD. Trends in the surgical treatment of lumbar spine disease in the United States. Spine J. 2015 Aug 1;15(8):1719-27. doi: 10.1016/j.spinee.2013.10.014. Epub 2013 Oct 31.
- Background: PubMed 27927514Amirouche F, Solitro GF, Magnan BP. Stability and Spine Pedicle Screws Fixation Strength-A Comparative Study of Bone Density and Insertion Angle. Spine Deform. 2016 Jul;4(4):261-267. doi: 10.1016/j.jspd.2015.12.008. Epub 2016 Jun 16.
- Background: PubMed 14588296Okuyama K, Abe E, Suzuki T, Tamura Y, Chiba M, Sato K. Influence of bone mineral density on pedicle screw fixation: a study of pedicle screw fixation augmenting posterior lumbar interbody fusion in elderly patients. Spine J. 2001 Nov-Dec;1(6):402-7. doi: 10.1016/s1529-9430(01)00078-x.
- Background: PubMed 27312862Bredow J, Boese CK, Werner CM, Siewe J, Lohrer L, Zarghooni K, Eysel P, Scheyerer MJ. Predictive validity of preoperative CT scans and the risk of pedicle screw loosening in spinal surgery. Arch Orthop Trauma Surg. 2016 Aug;136(8):1063-7. doi: 10.1007/s00402-016-2487-8. Epub 2016 Jun 16.
- Background: PubMed 25616349Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication? Eur Spine J. 2015 May;24(5):1005-16. doi: 10.1007/s00586-015-3768-6. Epub 2015 Jan 24.
- Background: PubMed 18404111Tokuhashi Y, Matsuzaki H, Oda H, Uei H. Clinical course and significance of the clear zone around the pedicle screws in the lumbar degenerative disease. Spine (Phila Pa 1976). 2008 Apr 15;33(8):903-8. doi: 10.1097/BRS.0b013e31816b1eff.
- Background: PubMed 26378363Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.
- Background: PubMed 28108403Janssen I, Ryang YM, Gempt J, Bette S, Gerhardt J, Kirschke JS, Meyer B. Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine. Spine J. 2017 Jun;17(6):837-844. doi: 10.1016/j.spinee.2017.01.009. Epub 2017 Jan 17.
- Background: PubMed 31899883Zou D, Muheremu A, Sun Z, Zhong W, Jiang S, Li W. Computed tomography Hounsfield unit-based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. J Neurosurg Spine. 2020 Jan 3;32(5):716-721. doi: 10.3171/2019.11.SPINE19868. Print 2020 May 1.
- Background: PubMed 31725127Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.
- Background: PubMed 30306332Zou D, Li W, Deng C, Du G, Xu N. The use of CT Hounsfield unit values to identify the undiagnosed spinal osteoporosis in patients with lumbar degenerative diseases. Eur Spine J. 2019 Aug;28(8):1758-1766. doi: 10.1007/s00586-018-5776-9. Epub 2018 Oct 10.
- Individual participant dataSharing planned: Yes. We will make the clinical study report available half a year after the publication of the results of the study.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Weishi Li, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Degenerative Lumbar Diseases, run by Peking University Third Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. 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 China. 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?
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?
Pedicle screw loosening (time frame: 12 months). The study lists 2 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 NCT04399421, which also lists 11 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 12 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.