Hip FracturesNCT04005404

Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

A study testing Ropivacaine (sciatic nerve block), Ropivacaine (lumbar plexus block L2-L4) and Ropivacaine (lumbar plexus block Th12-L1) in people with Hip Fractures, run by Helios Research Center at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hip Fractures
What is being tested?: Ropivacaine (sciatic nerve block), Ropivacaine (lumbar plexus block L2-L4) and Ropivacaine (lumbar plexus block Th12-L1)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteGermany
Study dates: 5 Aug 2019to 30 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

proximal femoral fracture
older then 18 years
written informed consent

Who cannot join

local or systematic inflammation
allergy to ropivacaine
participate in other studies
body mass index over 35
periprosthetic fractures

Trial locations and contacts

1 site in 1 country.

Germany1 site

Helios Medical Center Schwerin, Department of Anesthesiology
Schwerin, Mecklenburg-Vorpommern, 19049

Other trials in Germany

About this study

Official title: Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

Read the detailed description

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).

The injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine).

The study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.

Conditions: Hip Fractures
Being tested: Ropivacaine (sciatic nerve block), Ropivacaine (lumbar plexus block L2-L4), Ropivacaine (lumbar plexus block Th12-L1)
Keywords: Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus
Medical subject headings: Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropivacaine (sciatic nerve block)Drug
Also called parasacral sciatic nerve block (sacral plexus)
injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4)Drug
Also called posts compartment block (lumbar plexus L2-L4)
injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1)Drug
Also called transmuscular quadratus lumborum block (lumbar plexus Th12-L1)
injection of 20 ml ropivacaine 0.375%

Study groups in NCT04005404
Study group	Role	What they receive
intertrochanteric femoral fractures	Experimental	geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention Receives: Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)
neck femur fractures	Experimental	geriatric patients with neck of femur fracture who have consented to the study intervention Receives: Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)
subtrochanteric femoral fractures	Experimental	geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention Receives: Drug: Ropivacaine (sciatic nerve block); Drug: Ropivacaine (lumbar plexus block L2-L4); Drug: Ropivacaine (lumbar plexus block Th12-L1)

What is being measured

The primary outcome is the main question the study is designed to answer.

Success Rate (Supplemental Medication)
number of participants with need for supplemental analgesic medication (sufentanil)
Measured: during surgery
Success Rate (Conversion to General Anesthesia)
number of participants with need for conversion to general anesthesia
Measured: during surgery

Secondary outcomes (1)

Circulation Stability
number of participants with need for application of ephedrine and/or norepinephrine
Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201930 Jun 2020

First posted2 Jul 2019
Study start5 Aug 2019
Primary completion29 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Hip FracturesStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04005404
Sponsor's protocol ID: A 2018 0237
Status last verified: Feb 2021
First submitted: 29 Jun 2019
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
PubMed 30386022
Akkaya T, Comert A, Kendir S, Acar HI, Gumus H, Tekdemir I, Elhan A. Detailed anatomy of accessory obturator nerve blockade. Minerva Anestesiol. 2008 Apr;74(4):119-22.
PubMed 18354367
Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
PubMed 9479711
Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
PubMed 29397119
Duan X, Coburn M, Rossaint R, Sanders RD, Waesberghe JV, Kowark A. Efficacy of perioperative dexmedetomidine on postoperative delirium: systematic review and meta-analysis with trial sequential analysis of randomised controlled trials. Br J Anaesth. 2018 Aug;121(2):384-397. doi: 10.1016/j.bja.2018.04.046. Epub 2018 Jun 22.
PubMed 30032877
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657
Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.
PubMed 26899415
Guay J, Parker MJ, Griffiths R, Kopp SL. Peripheral Nerve Blocks for Hip Fractures: A Cochrane Review. Anesth Analg. 2018 May;126(5):1695-1704. doi: 10.1213/ANE.0000000000002489.
PubMed 28991122
Johnston DF, Stafford M, McKinney M, Deyermond R, Dane K. Peripheral nerve blocks with sedation using propofol and alfentanil target-controlled infusion for hip fracture surgery: a review of 6 years in use. J Clin Anesth. 2016 Mar;29:33-9. doi: 10.1016/j.jclinane.2015.10.012. Epub 2016 Feb 2.
PubMed 26897445
Nielsen TD, Moriggl B, Soballe K, Kolsen-Petersen JA, Borglum J, Bendtsen TF. A Cadaveric Study of Ultrasound-Guided Subpectineal Injectate Spread Around the Obturator Nerve and Its Hip Articular Branches. Reg Anesth Pain Med. 2017 May/Jun;42(3):357-361. doi: 10.1097/AAP.0000000000000587.
PubMed 28263244
Sa M, Graca R, Reis H, Cardoso JM, Sampaio J, Pinheiro C, Machado D. [Superior gluteal nerve: a new block on the block?]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):400-403. doi: 10.1016/j.bjan.2016.11.001. Epub 2017 May 24.
PubMed 28551063
Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
PubMed 26426575
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
PubMed 29140962
Taha AM. A simple and successful sonographic technique to identify the sciatic nerve in the parasacral area. Can J Anaesth. 2012 Mar;59(3):263-7. doi: 10.1007/s12630-011-9630-3. Epub 2011 Dec 3.
PubMed 22139964
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

All Hip Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study
ClinicalTrials.gov ID: NCT04005404
Acronym / sponsor ID: A 2018 0237
Conditions: Hip Fractures
Keywords: Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Helios Research CenterUniversity, hospital or other
Study start: 5 Aug 2019 (actual)
Primary completion: 29 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 2 Jul 2019 (actual)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

Detailed description

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"

Arm	Type	Receives
intertrochanteric femoral fractures	Experimental	Drug: Ropivacaine (sciatic nerve block), Drug: Ropivacaine (lumbar plexus block L2-L4), Drug: Ropivacaine (lumbar plexus block Th12-L1)geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention
neck femur fractures	Experimental	Drug: Ropivacaine (sciatic nerve block), Drug: Ropivacaine (lumbar plexus block L2-L4), Drug: Ropivacaine (lumbar plexus block Th12-L1)geriatric patients with neck of femur fracture who have consented to the study intervention
subtrochanteric femoral fractures	Experimental	Drug: Ropivacaine (sciatic nerve block), Drug: Ropivacaine (lumbar plexus block L2-L4), Drug: Ropivacaine (lumbar plexus block Th12-L1)geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

proximal femoral fracture
older then 18 years
written informed consent

Key exclusion criteria (5 listed)

local or systematic inflammation
allergy to ropivacaine
participate in other studies
body mass index over 35
periprosthetic fractures

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
Ropivacaine (sciatic nerve block)Also: parasacral sciatic nerve block (sacral plexus)injection of 20 ml ropivacaine 0.375%	Drug	intertrochanteric femoral fractures, neck femur fractures, subtrochanteric femoral fractures
Ropivacaine (lumbar plexus block L2-L4)Also: posts compartment block (lumbar plexus L2-L4)injection of 20 ml ropivacaine 0.375%	Drug	intertrochanteric femoral fractures, neck femur fractures, subtrochanteric femoral fractures
Ropivacaine (lumbar plexus block Th12-L1)Also: transmuscular quadratus lumborum block (lumbar plexus Th12-L1)injection of 20 ml ropivacaine 0.375%	Drug	intertrochanteric femoral fractures, neck femur fractures, subtrochanteric femoral fractures

Primary outcome

Success Rate (Supplemental Medication)
Time frame: during surgery
number of participants with need for supplemental analgesic medication (sufentanil)
Success Rate (Conversion to General Anesthesia)
Time frame: during surgery
number of participants with need for conversion to general anesthesia

1 secondary outcome

Circulation Stability
Time frame: during surgery

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intertrochanteric Femoral Fractures	43	42
Neck Femur Fractures	34	33
Subtrochanteric Femoral Fractures	3	3

Primary outcome: Success Rate (Supplemental Medication)

Time frame: during surgery. Count of participants. Unit: Participants

Measure	Intertrochanteric Femoral Fractures n = 42	Neck Femur Fractures n = 33	Subtrochanteric Femoral Fractures n = 3
Value	22	20	3

Primary outcome: Success Rate (Conversion to General Anesthesia)

Time frame: during surgery. Count of participants. Unit: Participants

Measure	Intertrochanteric Femoral Fractures n = 42	Neck Femur Fractures n = 33	Subtrochanteric Femoral Fractures n = 3
Value	1	3	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days after surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intertrochanteric Femoral Fractures	21 of 42 (50%)	0 of 42 (0%)	6 of 42
Neck Femur Fractures	16 of 33 (48.5%)	0 of 33 (0%)	3 of 33
Subtrochanteric Femoral Fractures	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30386022Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
Background: PubMed 18354367Akkaya T, Comert A, Kendir S, Acar HI, Gumus H, Tekdemir I, Elhan A. Detailed anatomy of accessory obturator nerve blockade. Minerva Anestesiol. 2008 Apr;74(4):119-22.
Background: PubMed 9479711Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
Background: PubMed 29397119Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
Background: PubMed 30032877Duan X, Coburn M, Rossaint R, Sanders RD, Waesberghe JV, Kowark A. Efficacy of perioperative dexmedetomidine on postoperative delirium: systematic review and meta-analysis with trial sequential analysis of randomised controlled trials. Br J Anaesth. 2018 Aug;121(2):384-397. doi: 10.1016/j.bja.2018.04.046. Epub 2018 Jun 22.
Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Background: PubMed 26899415Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.
Background: PubMed 28991122Guay J, Parker MJ, Griffiths R, Kopp SL. Peripheral Nerve Blocks for Hip Fractures: A Cochrane Review. Anesth Analg. 2018 May;126(5):1695-1704. doi: 10.1213/ANE.0000000000002489.
Background: PubMed 26897445Johnston DF, Stafford M, McKinney M, Deyermond R, Dane K. Peripheral nerve blocks with sedation using propofol and alfentanil target-controlled infusion for hip fracture surgery: a review of 6 years in use. J Clin Anesth. 2016 Mar;29:33-9. doi: 10.1016/j.jclinane.2015.10.012. Epub 2016 Feb 2.
Background: PubMed 28263244Nielsen TD, Moriggl B, Soballe K, Kolsen-Petersen JA, Borglum J, Bendtsen TF. A Cadaveric Study of Ultrasound-Guided Subpectineal Injectate Spread Around the Obturator Nerve and Its Hip Articular Branches. Reg Anesth Pain Med. 2017 May/Jun;42(3):357-361. doi: 10.1097/AAP.0000000000000587.
Background: PubMed 28551063Sa M, Graca R, Reis H, Cardoso JM, Sampaio J, Pinheiro C, Machado D. [Superior gluteal nerve: a new block on the block?]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):400-403. doi: 10.1016/j.bjan.2016.11.001. Epub 2017 May 24.
Background: PubMed 26426575Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 18 Feb 2021. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Success Rate (Supplemental Medication) (time frame: during surgery). 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 NCT04005404, which also lists 17 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 18 Feb 2021.