Hallux ValgusNCT03669900
Outcomes of Hallux Valgus Correction Surgery
A study testing a minimally invasive surgery (SERI) in people with Hallux Valgus, run by Security Forces Hospital at 1 site in Saudi Arabia.
Trial summary
HV correction surgery using SERI appear to sufficiently reduce the severity of HV deformity in all radiological measurements (HVA, IMA, DMAA) and the correction of subluxation of the first MTP joint and the sesamoids. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- a minimally invasive surgery (SERI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Mar 2018to 25 Aug 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All adult patients aged 20 years old to 60 years old admitted and managed for hallux valgus during the last 3 years (2013 - 2016) at Security Forces Hospital, Riyadh, Saudi Arabia.
- Reducible mild or moderate HV, HVA of ≤40o, IMA ≤20o with some severe cases.
- Patient with arthritis of the 1st MTP joint up to grade 2 according to the Regnauld's classification
- At least 2 years of follow-up in the hospital.
Who cannot join
- Patients who have stiffness of the first MTP joint
- Patients with severe arthritis of the first MTP joint (more than Regnauld's grade 2)
- Patients with history of rheumatoid arthritis or other inflammatory diseases, diabetics.
- Patients with neurological disorders.
- Patients with prior hallux surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological Measurements in Patients With Mild to Severe Hallux Valgus After Correction Surgery (SERI)
HV correction surgery using SERI appear to sufficiently reduce the severity of HV deformity in all radiological measurements (HVA, IMA, DMAA) and the correction of subluxation of the first MTP joint and the sesamoids. SERI technique is an easy, inexpensive, less invasive, more cosmetic, with shorter operative time and with minimal complication rates.
To our knowledge, there is no report regarding HV treatment using SERI from Saudi Arabia or in any part of the Middle East. Therefore, this study conducted to determine the radiological measurements done preoperatively and compare the measurements done at one year postoperatively, recording the complication happened and measuring the cost effectiveness of such procedure.
Read the detailed description
Hallux valgus (HV) is defined as a complex deformity where there is a lateral deviation of the proximal phalanx on the first metatarsal head (hallux) that is frequently associated with medial deviation of the first metatarsal, which may sometimes be accompanied by a significant functional disability and foot pain. Worldwide estimates from reports show a prevalence of 23% among adults below 65 years old and 35.7% among adults >65 years old, higher among females, and directly proportional to increasing age.
Because of the concomitant pain and other functional disability with HV, surgery is indicated usually depending on the degree of deformity based on the radiological findings as well as the physical examination findings. Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o.
There were a multitude of modern concepts in the surgical treatment of HV, including the Keller's procedure, the distal soft-tissue procedure, osteotomies of the first metatarsal, distal metatarsal osteotomies (Wilson procedure, Mitchell osteotomy, distal Chevron osteotomy), and many other type of surgeries including diaphyseal osteotomies and arthrodesis. Most of these surgical procedures were shown to provide morphologic and functional re-balance after surgery. While there are more than 150 surgical procedures described to treat HV, none of them is considered as a gold standard and each one had it is own advantages and disadvantages.
Minimally invasive techniques for correction of HV include arthroscopy, percutaneous and minimum incision surgery which were found to provide better outcome by decreasing recovery and rehabilitation time. On the other hand, some authors suggested that to correct HV deformity using SERI, a lateral soft tissue release should be performed first and reposition the sesamoids to avoid recurrence of the HV.
The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy. It is a type of distal first metatarsal osteotomy. Several studies using SERI have shown adequate correction of the deformity without avascular necrosis of the metatarsal head, pseudoarthrosis or recurrence.
Radiographic assessment including angular radiological parameters, sesamoid subluxation, and the articular congruency were shown to prove adequate correction of angular HV deformities. Preoperatively, measuring the axial view of the sesamoid position in the radiographic assessment of HV was proven to guide the surgeon on the appropriate surgical technique. Furthermore, measurements of the HVA and the IMA were recommended to evaluate preoperative assessment of the severity of HV and postoperative outcome of surgical treatment of HV.
- Conditions
- Hallux Valgus
- Being tested
- a minimally invasive surgery (SERI)
- Keywords
- SERI, correction surgery, Complications, radiological, outcomes
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a minimally invasive surgery (SERI)Procedure or surgery
The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| a minimally invasive surgery (SERI) | Other | The surgery consisted of varus traction, skin incision, metatarsal osteotomy and K- wire insertion. All the cases were done by the senior consultant orthopedic surgeon, including preoperative planning, the osteotomy itself and the follow up in the clinic. Another orthopedic surgeon was involved in collecting the data, doing all the measurements preoperative and postoperative and assisting the primary surgeon during the surgery. Receives: Procedure: a minimally invasive surgery (SERI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological measurements
Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Mar 2018
- Primary completion30 Jul 2018
- Study completion25 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raheef Alatassi, Security Forces Hospital
- Investigators
- Talal Almalki, FRCS, Study director, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669900
- Sponsor's protocol ID
- Hallux Valgus and SERI
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21.
PubMed 20868524Roddy E, Zhang W, Doherty M. Prevalence and associations of hallux valgus in a primary care population. Arthritis Rheum. 2008 Jun 15;59(6):857-62. doi: 10.1002/art.23709.
PubMed 18512715Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
PubMed 16049235Giannini S, Cavallo M, Faldini C, Luciani D, Vannini F. The SERI distal metatarsal osteotomy and Scarf osteotomy provide similar correction of hallux valgus. Clin Orthop Relat Res. 2013 Jul;471(7):2305-11. doi: 10.1007/s11999-013-2912-z. Epub 2013 Mar 14.
PubMed 23494184Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
PubMed 20710024Wu GB, Yang YF, Yu GR, Li B. Comment on Giannini et al.: A minimally invasive technique for surgical treatment of hallux valgus: simple, effective, rapid, inexpensive (SERI). Int Orthop. 2014 Mar;38(3):671-2. doi: 10.1007/s00264-013-2209-6. Epub 2013 Dec 5. No abstract available.
PubMed 24326360Giannini S, Faldini C, Nanni M, Di Martino A, Luciani D, Vannini F. A minimally invasive technique for surgical treatment of hallux valgus: simple, effective, rapid, inexpensive (SERI). Int Orthop. 2013 Sep;37(9):1805-13. doi: 10.1007/s00264-013-1980-8. Epub 2013 Jul 3.
PubMed 23820757Wagner E, Ortiz C, Torres K, Contesse I, Vela O, Zanolli D. Cost effectiveness of different techniques in hallux valgus surgery. Foot Ankle Surg. 2016 Dec;22(4):259-264. doi: 10.1016/j.fas.2015.11.004. Epub 2015 Dec 2.
PubMed 27810025Trnka HJ, Krenn S, Schuh R. Minimally invasive hallux valgus surgery: a critical review of the evidence. Int Orthop. 2013 Sep;37(9):1731-5. doi: 10.1007/s00264-013-2077-0. Epub 2013 Aug 29.
PubMed 23989262Lin YC, Cheng YM, Chang JK, Chen CH, Huang PJ. Minimally invasive distal metatarsal osteotomy for mild-to-moderate hallux valgus deformity. Kaohsiung J Med Sci. 2009 Aug;25(8):431-7. doi: 10.1016/S1607-551X(09)70538-8.
PubMed 19605337Thordarson D, Ebramzadeh E, Moorthy M, Lee J, Rudicel S. Correlation of hallux valgus surgical outcome with AOFAS forefoot score and radiological parameters. Foot Ankle Int. 2005 Feb;26(2):122-7. doi: 10.1177/107110070502600202.
PubMed 15737253Nery C, Coughlin MJ, Baumfeld D, Ballerini FJ, Kobata S. Hallux valgus in males--part 2: radiographic assessment of surgical treatment. Foot Ankle Int. 2013 May;34(5):636-44. doi: 10.1177/1071100713475351. Epub 2013 Jan 30.
PubMed 23637233Catanese D, Popowitz D, Gladstein AZ. Measuring sesamoid position in hallux valgus: when is the sesamoid axial view necessary? Foot Ankle Spec. 2014 Dec;7(6):457-9. doi: 10.1177/1938640014539804. Epub 2014 Jul 7.
PubMed 25005702Shima H, Okuda R, Yasuda T, Jotoku T, Kitano N, Kinoshita M. Radiographic measurements in patients with hallux valgus before and after proximal crescentic osteotomy. J Bone Joint Surg Am. 2009 Jun;91(6):1369-76. doi: 10.2106/JBJS.H.00483.
PubMed 19487514Coughlin MJ, Freund E. Roger A. Mann Award . The reliability of angular measurements in hallux valgus deformities. Foot Ankle Int. 2001 May;22(5):369-79. doi: 10.1177/107110070102200503.
PubMed 11428754
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Measurements in Patients With Mild to Severe Hallux Valgus After Correction Surgery (SERI)
- ClinicalTrials.gov ID
- NCT03669900
- Acronym / sponsor ID
- Hallux Valgus and SERI
- Conditions
- Hallux Valgus
- Keywords
- SERI, correction surgery, Complications, radiological, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 13 Sep 2018 (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.
HV correction surgery using SERI appear to sufficiently reduce the severity of HV deformity in all radiological measurements (HVA, IMA, DMAA) and the correction of subluxation of the first MTP joint and the sesamoids. SERI technique is an easy, inexpensive, less invasive, more cosmetic, with shorter operative time and with minimal complication rates.
To our knowledge, there is no report regarding HV treatment using SERI from Saudi Arabia or in any part of the Middle East. Therefore, this study conducted to determine the radiological measurements done preoperatively and compare the measurements done at one year postoperatively, recording the complication happened and measuring the cost effectiveness of such procedure.
Detailed description
Hallux valgus (HV) is defined as a complex deformity where there is a lateral deviation of the proximal phalanx on the first metatarsal head (hallux) that is frequently associated with medial deviation of the first metatarsal, which may sometimes be accompanied by a significant functional disability and foot pain. Worldwide estimates from reports show a prevalence of 23% among adults below 65 years old and 35.7% among adults >65 years old, higher among females, and directly proportional to increasing age.
Because of the concomitant pain and other functional disability with HV, surgery is indicated usually depending on the degree of deformity based on the radiological findings as well as the physical examination findings. Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o.
There were a multitude of modern concepts in the surgical treatment of HV, including the Keller's procedure, the distal soft-tissue procedure, osteotomies of the first metatarsal, distal metatarsal osteotomies (Wilson procedure, Mitchell osteotomy, distal Chevron osteotomy), and many other type of surgeries including diaphyseal osteotomies and arthrodesis. Most of these surgical procedures were shown to provide morphologic and functional re-balance after surgery. While there are more than 150 surgical procedures described to treat HV, none of them is considered as a gold standard and each one had it is own advantages and disadvantages.
Minimally invasive techniques for correction of HV include arthroscopy, percutaneous and minimum incision surgery which were found to provide better outcome by decreasing recovery and rehabilitation time. On the other hand, some authors suggested that to correct HV deformity using SERI, a lateral soft tissue release should be performed first and reposition the sesamoids to avoid recurrence of the HV.
The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy. It is a type of distal first metatarsal osteotomy. Several studies using SERI have shown adequate correction of the deformity without avascular necrosis of the metatarsal head, pseudoarthrosis or recurrence.
Radiographic assessment including angular radiological parameters, sesamoid subluxation, and the articular congruency were shown to prove adequate correction of angular HV deformities. Preoperatively, measuring the axial view of the sesamoid position in the radiographic assessment of HV was proven to guide the surgeon on the appropriate surgical technique. Furthermore, measurements of the HVA and the IMA were recommended to evaluate preoperative assessment of the severity of HV and postoperative outcome of surgical treatment of HV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a minimally invasive surgery (SERI) | Other | Procedure: a minimally invasive surgery (SERI)The surgery consisted of varus traction, skin incision, metatarsal osteotomy and K- wire insertion. All the cases were done by the senior consultant orthopedic surgeon, including preoperative planning, the osteotomy itself and the follow up in the clinic. Another orthopedic surgeon was involved in collecting the data, doing all the measurements preoperative and postoperative and assisting the primary surgeon during the surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All adult patients aged 20 years old to 60 years old admitted and managed for hallux valgus during the last 3 years (2013 - 2016) at Security Forces Hospital, Riyadh, Saudi Arabia.
- Reducible mild or moderate HV, HVA of ≤40o, IMA ≤20o with some severe cases.
- Patient with arthritis of the 1st MTP joint up to grade 2 according to the Regnauld's classification
- At least 2 years of follow-up in the hospital.
Key exclusion criteria (5 listed)
- Patients who have stiffness of the first MTP joint
- Patients with severe arthritis of the first MTP joint (more than Regnauld's grade 2)
- Patients with history of rheumatoid arthritis or other inflammatory diseases, diabetics.
- Patients with neurological disorders.
- Patients with prior hallux surgery.
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 |
|---|---|---|
| a minimally invasive surgery (SERI)The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy | Procedure or surgery | a minimally invasive surgery (SERI) |
Primary outcome
radiological measurements
Time frame: one year
Radiological assessment includes weight-bearing anteroposterior (AP) and lateral imaging of the foot. The severity of the deformity is usually classified as mild, when the hallux valgus angle (HVA) is up to 19o , intermetatarsal angle (IMA) up to 13o; moderate when HVA is 20o to 40o; and severe when HVA is >40o and IMA >20o
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Background: PubMed 20868524Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21.
- Background: PubMed 18512715Roddy E, Zhang W, Doherty M. Prevalence and associations of hallux valgus in a primary care population. Arthritis Rheum. 2008 Jun 15;59(6):857-62. doi: 10.1002/art.23709.
- Background: PubMed 16049235Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
- Background: PubMed 23494184Giannini S, Cavallo M, Faldini C, Luciani D, Vannini F. The SERI distal metatarsal osteotomy and Scarf osteotomy provide similar correction of hallux valgus. Clin Orthop Relat Res. 2013 Jul;471(7):2305-11. doi: 10.1007/s11999-013-2912-z. Epub 2013 Mar 14.
- Background: PubMed 20710024Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
- Background: PubMed 24326360Wu GB, Yang YF, Yu GR, Li B. Comment on Giannini et al.: A minimally invasive technique for surgical treatment of hallux valgus: simple, effective, rapid, inexpensive (SERI). Int Orthop. 2014 Mar;38(3):671-2. doi: 10.1007/s00264-013-2209-6. Epub 2013 Dec 5. No abstract available.
- Background: PubMed 23820757Giannini S, Faldini C, Nanni M, Di Martino A, Luciani D, Vannini F. A minimally invasive technique for surgical treatment of hallux valgus: simple, effective, rapid, inexpensive (SERI). Int Orthop. 2013 Sep;37(9):1805-13. doi: 10.1007/s00264-013-1980-8. Epub 2013 Jul 3.
- Background: PubMed 27810025Wagner E, Ortiz C, Torres K, Contesse I, Vela O, Zanolli D. Cost effectiveness of different techniques in hallux valgus surgery. Foot Ankle Surg. 2016 Dec;22(4):259-264. doi: 10.1016/j.fas.2015.11.004. Epub 2015 Dec 2.
- Background: PubMed 23989262Trnka HJ, Krenn S, Schuh R. Minimally invasive hallux valgus surgery: a critical review of the evidence. Int Orthop. 2013 Sep;37(9):1731-5. doi: 10.1007/s00264-013-2077-0. Epub 2013 Aug 29.
- Background: PubMed 19605337Lin YC, Cheng YM, Chang JK, Chen CH, Huang PJ. Minimally invasive distal metatarsal osteotomy for mild-to-moderate hallux valgus deformity. Kaohsiung J Med Sci. 2009 Aug;25(8):431-7. doi: 10.1016/S1607-551X(09)70538-8.
- Background: PubMed 15737253Thordarson D, Ebramzadeh E, Moorthy M, Lee J, Rudicel S. Correlation of hallux valgus surgical outcome with AOFAS forefoot score and radiological parameters. Foot Ankle Int. 2005 Feb;26(2):122-7. doi: 10.1177/107110070502600202.
- Background: PubMed 23637233Nery C, Coughlin MJ, Baumfeld D, Ballerini FJ, Kobata S. Hallux valgus in males--part 2: radiographic assessment of surgical treatment. Foot Ankle Int. 2013 May;34(5):636-44. doi: 10.1177/1071100713475351. Epub 2013 Jan 30.
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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.
Talal Almalki, FRCS study director
Security Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a minimally invasive surgery (SERI) in people with Hallux Valgus, run by Security Forces Hospital at 1 site in Saudi Arabia.
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 5 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: finished, as of the sponsor's last update on 17 Sep 2018. 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 Saudi Arabia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
radiological measurements (time frame: one year). 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 NCT03669900, which also lists 16 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 17 Sep 2018.