Developmental Dysplasia of HipNCT03275805
Should Graf IIc Hips be Treated for 12 Weeks
A study testing Duration of Pavlik Harness treatment in people with Developmental Dysplasia of Hip, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized depending on the severity of their hip malformation. Regardless of the severity, the accepted form of treatment is the Pavlik Harness. Read more about this study
- Who is it for?
- Ages 0 to 18 weeks
- Conditions the study is for
- Developmental Dysplasia of Hip
- What is being tested?
- Duration of Pavlik Harness treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 1 Jul 2025
- 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 0 to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Patients with:
- DDH
- Graf IIc hips (alpha angle = 43-49 degrees)
- normal hip exam (stable hips)
- abnormal ultrasound
Who cannot join
- Patients with additional conditions: Neurologic or teratologic.
- Follow up that occurs at any other institution.
- Unstable hips
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?
Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized depending on the severity of their hip malformation. Regardless of the severity, the accepted form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended treatment regarding length of Pavlik Harness treatment for patients with DDH who have who have been categorized with stable Graf type IIc hips. The investigators will aim to answer this question with a randomized controlled trial of patients with these specific findings by dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time). Patient's two year follow up radiographs will determine the best means of treatment.
Read the detailed description
Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if treated correctly. While the literature agrees that Pavlik Harness treatment is the best means of treatment, there is still a lack of research regarding those patients who have stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia with a categorical method based on physical exam and ultrasound findings with a range of I-IV given in increasing order of severity. There are recommendations for how to treat more severe forms, but there is no consensus among orthopedic surgeons on how to specifically treat type IIc hips who present with stable hips.
Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle <60 degrees, and less than 50% coverage and is justification in the facility for entrance into our designated hip protocol.
Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and will randomly divide patients into one of two arms: one control group which will receive the standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and one experimental group which will receive full-time Pavlik Harness treatment until normalization, but for no less than 6 weeks. All patients will be required to follow up at week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6 months; radiographs will be taken at patients 6 month, one year and two year follow ups due to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be used as the primary outcome variable.
Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the associated complication/failure will be noted, patients will be ineligible for study inclusion, and will continue with treatment to ensure hip reduction.
At routine follow ups, providers will note patient alpha angles on ultrasound at weeks 1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from within EPIC after patient visits and data information will be stored in RedCAP until the remainder of the study. Demographic and clinical characteristics will be included through descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will determine if 6 weeks of treatment is no less harmful in terms of incidences of residual dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4 degrees. This is the chosen clinically accepted difference in AI between groups.
- Conditions
- Developmental Dysplasia of Hip
- Being tested
- Duration of Pavlik Harness treatment, 12 week standard of care
- Keywords
- DDH, Pavlik Harness, dysplasia
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of Pavlik Harness treatmentOther
The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.
12 week standard of careOther
The intervention for this arm will be standard treatment for this pathology.
| Study group | Role | What they receive |
|---|---|---|
| 12 weeks Pavlik Treatment Arm | Active comparator | This arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic. Receives: Other: 12 week standard of care |
| 6 weeks Pavlik Treatment Arm | Experimental | This arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic. Receives: Other: Duration of Pavlik Harness treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Index at 2 years
AI is a categorical measure that can be calculated on routine radiographs (X-rays). This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket). AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start11 Jun 2021
- Primary completion21 Aug 2024
- Study completion1 Jul 2025
Why it stopped: Study team determined that recruiting eligible patients is not feasible. Additionally, the PI retired in 01/2025.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of HipStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaia Georgopoulos, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275805
- Sponsor's protocol ID
- 20-3104
- Status last verified
- Jul 2025
- First submitted
- 21 Nov 2016
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing. Data is in RedCAP and will only be available for listed authors.
Publications
Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
PubMed 9917445Dunn PM, Evans RE, Thearle MJ, Griffiths HE, Witherow PJ. Congenital dislocation of the hip: early and late diagnosis and management compared. Arch Dis Child. 1985 May;60(5):407-14. doi: 10.1136/adc.60.5.407.
PubMed 4015144Harding MG, Harcke HT, Bowen JR, Guille JT, Glutting J. Management of dislocated hips with Pavlik harness treatment and ultrasound monitoring. J Pediatr Orthop. 1997 Mar-Apr;17(2):189-98. doi: 10.1097/00004694-199703000-00010.
PubMed 9075094Herring JA. Conservative treatment of congenital dislocation of the hip in the newborn and infant. Clin Orthop Relat Res. 1992 Aug;(281):41-7.
PubMed 1499226Lorente Molto FJ, Gregori AM, Casas LM, Perales VM. Three-year prospective study of developmental dysplasia of the hip at birth: should all dislocated or dislocatable hips be treated? J Pediatr Orthop. 2002 Sep-Oct;22(5):613-21.
PubMed 12198463Mubarak S, Garfin S, Vance R, McKinnon B, Sutherland D. Pitfalls in the use of the Pavlik harness for treatment of congenital dysplasia, subluxation, and dislocation of the hip. J Bone Joint Surg Am. 1981 Oct;63(8):1239-48.
PubMed 7287794Novais EN, Sanders J, Kestel LA, Carry PM, Meyers ML. Graf Type-IV Hips Have a Higher Risk of Residual Acetabular Dysplasia at 1 Year of Age Following Successful Pavlik Harness Treatment for Developmental Hip Dysplasia. J Pediatr Orthop. 2018 Nov/Dec;38(10):498-502. doi: 10.1097/BPO.0000000000000875.
PubMed 27662383Paton RW, Hopgood PJ, Eccles K. Instability of the neonatal hip: the role of early or late splintage. Int Orthop. 2004 Oct;28(5):270-3. doi: 10.1007/s00264-004-0576-8. Epub 2004 Aug 12.
PubMed 15309324Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, Alsaker T, Moster D, Lie RT, Markestad T. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.
PubMed 20026501Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.
PubMed 19934187Takahashi I. Functional treatment of congenital dislocation of the hip using Pavlik harness (Riemenbugel). Nihon Seikeigeka Gakkai Zasshi. 1985 Nov;59(11):973-84.
PubMed 3831166Westacott DJ, Mackay ND, Waton A, Webb MS, Henman P, Cooke SJ. Staged weaning versus immediate cessation of Pavlik harness treatment for developmental dysplasia of the hip. J Pediatr Orthop B. 2014 Mar;23(2):103-6. doi: 10.1097/BPB.0000000000000025.
PubMed 24322535Wood MK, Conboy V, Benson MK. Does early treatment by abduction splintage improve the development of dysplastic but stable neonatal hips? J Pediatr Orthop. 2000 May-Jun;20(3):302-5.
PubMed 10823594Atalar H, Sayli U, Yavuz OY, Uras I, Dogruel H. Indicators of successful use of the Pavlik harness in infants with developmental dysplasia of the hip. Int Orthop. 2007 Apr;31(2):145-50. doi: 10.1007/s00264-006-0097-8. Epub 2006 Apr 7.
PubMed 16601983Viere RG, Birch JG, Herring JA, Roach JW, Johnston CE. Use of the Pavlik harness in congenital dislocation of the hip. An analysis of failures of treatment. J Bone Joint Surg Am. 1990 Feb;72(2):238-44.
PubMed 2303510
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?
- ClinicalTrials.gov ID
- NCT03275805
- Acronym / sponsor ID
- 20-3104
- Conditions
- Developmental Dysplasia of Hip
- Keywords
- DDH, Pavlik Harness, dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team determined that recruiting eligible patients is not feasible. Additionally, the PI retired in 01/2025.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 8 Sep 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.
Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized depending on the severity of their hip malformation. Regardless of the severity, the accepted form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended treatment regarding length of Pavlik Harness treatment for patients with DDH who have who have been categorized with stable Graf type IIc hips. The investigators will aim to answer this question with a randomized controlled trial of patients with these specific findings by dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time). Patient's two year follow up radiographs will determine the best means of treatment.
Detailed description
Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if treated correctly. While the literature agrees that Pavlik Harness treatment is the best means of treatment, there is still a lack of research regarding those patients who have stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia with a categorical method based on physical exam and ultrasound findings with a range of I-IV given in increasing order of severity. There are recommendations for how to treat more severe forms, but there is no consensus among orthopedic surgeons on how to specifically treat type IIc hips who present with stable hips.
Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle <60 degrees, and less than 50% coverage and is justification in the facility for entrance into our designated hip protocol.
Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and will randomly divide patients into one of two arms: one control group which will receive the standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and one experimental group which will receive full-time Pavlik Harness treatment until normalization, but for no less than 6 weeks. All patients will be required to follow up at week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6 months; radiographs will be taken at patients 6 month, one year and two year follow ups due to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be used as the primary outcome variable.
Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the associated complication/failure will be noted, patients will be ineligible for study inclusion, and will continue with treatment to ensure hip reduction.
At routine follow ups, providers will note patient alpha angles on ultrasound at weeks 1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from within EPIC after patient visits and data information will be stored in RedCAP until the remainder of the study. Demographic and clinical characteristics will be included through descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will determine if 6 weeks of treatment is no less harmful in terms of incidences of residual dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4 degrees. This is the chosen clinically accepted difference in AI between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 weeks Pavlik Treatment Arm | Active comparator | Other: 12 week standard of careThis arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic. |
| 6 weeks Pavlik Treatment Arm | Experimental | Other: Duration of Pavlik Harness treatmentThis arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic. |
Who may qualify
- Ages
- 0 to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- DDH
- Graf IIc hips (alpha angle = 43-49 degrees)
- normal hip exam (stable hips)
- abnormal ultrasound
Key exclusion criteria (3 listed)
- Patients with additional conditions: Neurologic or teratologic.
- Follow up that occurs at any other institution.
- Unstable hips
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 |
|---|---|---|
| Duration of Pavlik Harness treatmentThe only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology. | Other | 6 weeks Pavlik Treatment Arm |
| 12 week standard of careThe intervention for this arm will be standard treatment for this pathology. | Other | 12 weeks Pavlik Treatment Arm |
Primary outcome
Acetabular Index at 2 years
Time frame: 2 year follow up
AI is a categorical measure that can be calculated on routine radiographs (X-rays). This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket). AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.
Results and safety
The study was stopped early (reason given: Study team determined that recruiting eligible patients is not feasible. Additionally, the PI retired in 01/2025.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 9917445Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
- Background: PubMed 4015144Dunn PM, Evans RE, Thearle MJ, Griffiths HE, Witherow PJ. Congenital dislocation of the hip: early and late diagnosis and management compared. Arch Dis Child. 1985 May;60(5):407-14. doi: 10.1136/adc.60.5.407.
- Background: PubMed 9075094Harding MG, Harcke HT, Bowen JR, Guille JT, Glutting J. Management of dislocated hips with Pavlik harness treatment and ultrasound monitoring. J Pediatr Orthop. 1997 Mar-Apr;17(2):189-98. doi: 10.1097/00004694-199703000-00010.
- Background: PubMed 1499226Herring JA. Conservative treatment of congenital dislocation of the hip in the newborn and infant. Clin Orthop Relat Res. 1992 Aug;(281):41-7.
- Background: PubMed 12198463Lorente Molto FJ, Gregori AM, Casas LM, Perales VM. Three-year prospective study of developmental dysplasia of the hip at birth: should all dislocated or dislocatable hips be treated? J Pediatr Orthop. 2002 Sep-Oct;22(5):613-21.
- Background: PubMed 7287794Mubarak S, Garfin S, Vance R, McKinnon B, Sutherland D. Pitfalls in the use of the Pavlik harness for treatment of congenital dysplasia, subluxation, and dislocation of the hip. J Bone Joint Surg Am. 1981 Oct;63(8):1239-48.
- Background: PubMed 27662383Novais EN, Sanders J, Kestel LA, Carry PM, Meyers ML. Graf Type-IV Hips Have a Higher Risk of Residual Acetabular Dysplasia at 1 Year of Age Following Successful Pavlik Harness Treatment for Developmental Hip Dysplasia. J Pediatr Orthop. 2018 Nov/Dec;38(10):498-502. doi: 10.1097/BPO.0000000000000875.
- Background: PubMed 15309324Paton RW, Hopgood PJ, Eccles K. Instability of the neonatal hip: the role of early or late splintage. Int Orthop. 2004 Oct;28(5):270-3. doi: 10.1007/s00264-004-0576-8. Epub 2004 Aug 12.
- Background: PubMed 20026501Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, Alsaker T, Moster D, Lie RT, Markestad T. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.
- Background: PubMed 19934187Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.
- Background: PubMed 3831166Takahashi I. Functional treatment of congenital dislocation of the hip using Pavlik harness (Riemenbugel). Nihon Seikeigeka Gakkai Zasshi. 1985 Nov;59(11):973-84.
- Background: PubMed 24322535Westacott DJ, Mackay ND, Waton A, Webb MS, Henman P, Cooke SJ. Staged weaning versus immediate cessation of Pavlik harness treatment for developmental dysplasia of the hip. J Pediatr Orthop B. 2014 Mar;23(2):103-6. doi: 10.1097/BPB.0000000000000025.
- Individual participant dataSharing planned: No. No sharing. Data is in RedCAP and will only be available for listed authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaia Georgopoulos, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of Pavlik Harness treatment in people with Developmental Dysplasia of Hip, run by University of Colorado, Denver 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 5 inclusion and 3 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 15 Jul 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Study team determined that recruiting eligible patients is not feasible. Additionally, the PI retired in 01/2025.). 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?
Acetabular Index at 2 years (time frame: 2 year follow up). 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 NCT03275805, which also lists 23 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 15 Jul 2025.