Tibial FracturesINSURTNCT02750072
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
A study testing Infrapatellar Approach and Suprapatellar Approach in people with Tibial Fractures and Anterior Knee Pain Syndrome, run by Fraser Orthopaedic Research Society at 6 sites in 2 countries.
Trial summary
This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tibial Fractures, Anterior Knee Pain Syndrome
- What is being tested?
- Infrapatellar Approach and Suprapatellar Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 13 Sep 2016to 12 Oct 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all extra-articular tibial fractures
- simple distal tibial intra-articular fractures amenable to IMN
- open and closed fractures
- bilateral tibiae
- willing and able to consent, follow protocol and attend follow-up visits
- able to read and understand English or have interpreter available
Who cannot join
- patients with contralateral femur and/or hip fracture requiring retrograde IMN
- patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
- associated knee injury
- previous symptomatic knee pathology
- ipsilateral injuries to the same limb that would interfere with rehab or outcome
- neurovascular injuries at the level of the knee requiring surgery
Show all 15Show fewer
- open or closed fractures > 14 days (times of injury to OR)
- non unions
- pathologic fractures
- periprosthetic fractures
- spinal injury
- non-ambulatory patients
- incarceration
- limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
- likely problems, in the judgment of the investigators, with maintaining follow-up
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
University of Alberta Hospital
Edmonton, Alberta
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7
Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, V3L 3W7
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
About this study
This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
Read the detailed description
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.
The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
- Conditions
- Tibial Fractures, Anterior Knee Pain Syndrome
- Being tested
- Infrapatellar Approach, Suprapatellar Approach
- Medical subject headings
- Tibial Fractures, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrapatellar ApproachProcedure or surgery
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Suprapatellar ApproachProcedure or surgery
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Infrapatellar approach | Active comparator | Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral). Receives: Procedure: Infrapatellar Approach |
| Semi-extended suprapatellar approach | Experimental | Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve). Receives: Procedure: Suprapatellar Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visual analog scale) for pain on kneeling/ability to knee
Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale
Measured: 12 months post treatment
Secondary outcomes (8)
AKT (Aberdeen Kneeling Weight-Distribution Test)
The AKT involves kneeling on two separate calibrated scales for up to 60 seconds with the patient blinded to the readings. At 15-second intervals the weight distribution, measured in kg, between the two knees is documented.
Measured: 4, 6, 12 and 24 months post treatment
AST (Aberdeen Standing Weight-Distribution Test)
The AST involves the patient standing on two separate calibrated scales (one foot on each scale) and the weight in kg recorded with the patient blinded to the readings.
Measured: 4, 6, 12 and 24 months post treatment
VAS (Visual Analog Scale) at rest, with walking and descending stairs
Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale
Measured: 4, 6, 12 and 24 months post treatment
Lysholm Knee Scoring Scale
Used to evaluate outcomes of knee ligament surgery using 8-items commonly affecting patients with anterior knee pain: Limp, support, locking, instability, pain, swelling, stair climbing and squatting.
Measured: 4, 6, 12 and 24 months post treatment
PKPM (Photographic knee pain map)
Used to determine the precise location of the knee pain, as indicated and localized by the participant.
Measured: 4, 6,12 and 24 months post treatment
EQ-5D Health Related Quality of Life Outcome Measure
5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 4, 6,12 and 24 months post treatment
WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem
A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities.
Measured: 4, 6, 12 and 24 months post treatment
Radiographic outcome
Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail.
Measured: Intra-operatively and 4, 6,12 and 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start13 Sep 2016
- Primary completion31 May 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Tibial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Darius G Viskontas, MD, FRCSC, Principal investigator, Royal Columbian Hospital / Fraser Health AuthorityTrevor B Stone, MD, FRCSC, Principal investigator, Royal Columbian Hospital / Fraser Health AuthorityAlan Johnstone, Professor, Principal investigator, Aberdeen Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750072
- Sponsor's protocol ID
- FHREB #: 2016-029
- Acronym
- INSURT
- Status last verified
- Sep 2023
- First submitted
- 18 Apr 2016
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Karachalios T, Babis G, Tsarouchas J, Sapkas G, Pantazopoulos T. The clinical performance of a small diameter tibial nailing system with a mechanical distal aiming device. Injury. 2000 Jul;31(6):451-9. doi: 10.1016/s0020-1383(00)00024-3.
PubMed 10831746Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg Am. 2002 Apr;84(4):580-5. doi: 10.2106/00004623-200204000-00011.
PubMed 11940618Katsoulis E, Court-Brown C, Giannoudis PV. Incidence and aetiology of anterior knee pain after intramedullary nailing of the femur and tibia. J Bone Joint Surg Br. 2006 May;88(5):576-80. doi: 10.1302/0301-620X.88B5.16875. No abstract available.
PubMed 16645100Weninger P, Schultz A, Traxler H, Firbas W, Hertz H. Anatomical assessment of the Hoffa fat pad during insertion of a tibial intramedullary nail--comparison of three surgical approaches. J Trauma. 2009 Apr;66(4):1140-5. doi: 10.1097/TA.0b013e318169cd4d.
PubMed 19359927Koval KJ, Clapper MF, Brumback RJ, Ellison PS Jr, Poka A, Bathon GH, Burgess AR. Complications of reamed intramedullary nailing of the tibia. J Orthop Trauma. 1991;5(2):184-9. doi: 10.1097/00005131-199105020-00011.
PubMed 1650401Ryan SP, Steen B, Tornetta P 3rd. Semi-extended nailing of metaphyseal tibia fractures: alignment and incidence of postoperative knee pain. J Orthop Trauma. 2014 May;28(5):263-9. doi: 10.1097/BOT.0000000000000083.
PubMed 24751605Jones M, Parry M, Whitehouse M, Mitchell S. Radiologic outcome and patient-reported function after intramedullary nailing: a comparison of the retropatellar and infrapatellar approach. J Orthop Trauma. 2014 May;28(5):256-62. doi: 10.1097/BOT.0000000000000070.
PubMed 24464093Vaisto O, Toivanen J, Paakkala T, Jarvela T, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of a tibial shaft fracture: an ultrasound study of the patellar tendons of 36 patients. J Orthop Trauma. 2005 May-Jun;19(5):311-6.
PubMed 15891539Leliveld MS, Verhofstad MH. Injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing? Injury. 2012 Jun;43(6):779-83. doi: 10.1016/j.injury.2011.09.002. Epub 2011 Oct 1.
PubMed 21962297Cartwright-Terry M, Snow M, Nalwad H. The severity and prediction of anterior knee pain post tibial nail insertion. J Orthop Trauma. 2007 Jul;21(6):381-5. doi: 10.1097/BOT.0b013e3180caa138.
PubMed 17620996Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft: an eight-year follow-up of a prospective, randomized study comparing two different nail-insertion techniques. J Trauma. 2008 Jun;64(6):1511-6. doi: 10.1097/TA.0b013e318031cd27.
PubMed 18545115Tornetta P 3rd, Collins E. Semiextended position of intramedullary nailing of the proximal tibia. Clin Orthop Relat Res. 1996 Jul;(328):185-9. doi: 10.1097/00003086-199607000-00029.
PubMed 8653954Sanders RW, DiPasquale TG, Jordan CJ, Arrington JA, Sagi HC. Semiextended intramedullary nailing of the tibia using a suprapatellar approach: radiographic results and clinical outcomes at a minimum of 12 months follow-up. J Orthop Trauma. 2014 Aug;28 Suppl 8:S29-39. doi: 10.1097/01.bot.0000452787.80923.ee.
PubMed 25046413Morandi M, Banka T, Gaiarsa GP, Guthrie ST, Khalil J, Hoegler J, Lindeque BG. Intramedullary nailing of tibial fractures: review of surgical techniques and description of a percutaneous lateral suprapatellar approach. Orthopedics. 2010 Mar;33(3):172-9. doi: 10.3928/01477447-20100129-22. No abstract available.
PubMed 20205366Kubiak EN, Widmer BJ, Horwitz DS. Extra-articular technique for semiextended tibial nailing. J Orthop Trauma. 2010 Nov;24(11):704-8. doi: 10.1097/BOT.0b013e3181d5d9f4.
PubMed 20881632
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
- ClinicalTrials.gov ID
- NCT02750072
- Acronym / sponsor ID
- INSURT / FHREB #: 2016-029
- Conditions
- Tibial Fractures, Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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 study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
Detailed description
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.
The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrapatellar approach | Active comparator | Procedure: Infrapatellar ApproachInfrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral). |
| Semi-extended suprapatellar approach | Experimental | Procedure: Suprapatellar ApproachSemi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- all extra-articular tibial fractures
- simple distal tibial intra-articular fractures amenable to IMN
- open and closed fractures
- bilateral tibiae
- willing and able to consent, follow protocol and attend follow-up visits
Key exclusion criteria (15 listed)
- patients with contralateral femur and/or hip fracture requiring retrograde IMN
- patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
- associated knee injury
- previous symptomatic knee pathology
- ipsilateral injuries to the same limb that would interfere with rehab or outcome
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 |
|---|---|---|
| Infrapatellar ApproachInfrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral) | Procedure or surgery | Infrapatellar approach |
| Suprapatellar ApproachSemi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation | Procedure or surgery | Semi-extended suprapatellar approach |
Primary outcome
VAS (visual analog scale) for pain on kneeling/ability to knee
Time frame: 12 months post treatment
Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale
8 secondary outcomes
AKT (Aberdeen Kneeling Weight-Distribution Test)
Time frame: 4, 6, 12 and 24 months post treatment
AST (Aberdeen Standing Weight-Distribution Test)
Time frame: 4, 6, 12 and 24 months post treatment
VAS (Visual Analog Scale) at rest, with walking and descending stairs
Time frame: 4, 6, 12 and 24 months post treatment
Lysholm Knee Scoring Scale
Time frame: 4, 6, 12 and 24 months post treatment
PKPM (Photographic knee pain map)
Time frame: 4, 6,12 and 24 months post treatment
EQ-5D Health Related Quality of Life Outcome Measure
Time frame: 4, 6,12 and 24 months post treatment
WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem
Time frame: 4, 6, 12 and 24 months post treatment
Radiographic outcome
Time frame: Intra-operatively and 4, 6,12 and 24 months post treatment
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 30 Jan 2024.
- Background: PubMed 10831746Karachalios T, Babis G, Tsarouchas J, Sapkas G, Pantazopoulos T. The clinical performance of a small diameter tibial nailing system with a mechanical distal aiming device. Injury. 2000 Jul;31(6):451-9. doi: 10.1016/s0020-1383(00)00024-3.
- Background: PubMed 11940618Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg Am. 2002 Apr;84(4):580-5. doi: 10.2106/00004623-200204000-00011.
- Background: PubMed 16645100Katsoulis E, Court-Brown C, Giannoudis PV. Incidence and aetiology of anterior knee pain after intramedullary nailing of the femur and tibia. J Bone Joint Surg Br. 2006 May;88(5):576-80. doi: 10.1302/0301-620X.88B5.16875. No abstract available.
- Background: PubMed 19359927Weninger P, Schultz A, Traxler H, Firbas W, Hertz H. Anatomical assessment of the Hoffa fat pad during insertion of a tibial intramedullary nail--comparison of three surgical approaches. J Trauma. 2009 Apr;66(4):1140-5. doi: 10.1097/TA.0b013e318169cd4d.
- Background: PubMed 1650401Koval KJ, Clapper MF, Brumback RJ, Ellison PS Jr, Poka A, Bathon GH, Burgess AR. Complications of reamed intramedullary nailing of the tibia. J Orthop Trauma. 1991;5(2):184-9. doi: 10.1097/00005131-199105020-00011.
- Background: PubMed 24751605Ryan SP, Steen B, Tornetta P 3rd. Semi-extended nailing of metaphyseal tibia fractures: alignment and incidence of postoperative knee pain. J Orthop Trauma. 2014 May;28(5):263-9. doi: 10.1097/BOT.0000000000000083.
- Background: PubMed 24464093Jones M, Parry M, Whitehouse M, Mitchell S. Radiologic outcome and patient-reported function after intramedullary nailing: a comparison of the retropatellar and infrapatellar approach. J Orthop Trauma. 2014 May;28(5):256-62. doi: 10.1097/BOT.0000000000000070.
- Background: PubMed 15891539Vaisto O, Toivanen J, Paakkala T, Jarvela T, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of a tibial shaft fracture: an ultrasound study of the patellar tendons of 36 patients. J Orthop Trauma. 2005 May-Jun;19(5):311-6.
- Background: PubMed 21962297Leliveld MS, Verhofstad MH. Injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing? Injury. 2012 Jun;43(6):779-83. doi: 10.1016/j.injury.2011.09.002. Epub 2011 Oct 1.
- Background: PubMed 17620996Cartwright-Terry M, Snow M, Nalwad H. The severity and prediction of anterior knee pain post tibial nail insertion. J Orthop Trauma. 2007 Jul;21(6):381-5. doi: 10.1097/BOT.0b013e3180caa138.
- Background: PubMed 18545115Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft: an eight-year follow-up of a prospective, randomized study comparing two different nail-insertion techniques. J Trauma. 2008 Jun;64(6):1511-6. doi: 10.1097/TA.0b013e318031cd27.
- Background: PubMed 8653954Tornetta P 3rd, Collins E. Semiextended position of intramedullary nailing of the proximal tibia. Clin Orthop Relat Res. 1996 Jul;(328):185-9. doi: 10.1097/00003086-199607000-00029.
- 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.
Darius G Viskontas, MD, FRCSC principal investigator
Royal Columbian Hospital / Fraser Health Authority
Trevor B Stone, MD, FRCSC principal investigator
Royal Columbian Hospital / Fraser Health Authority
Alan Johnstone, Professor principal investigator
Aberdeen Royal Infirmary
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrapatellar Approach and Suprapatellar Approach in people with Tibial Fractures and Anterior Knee Pain Syndrome, run by Fraser Orthopaedic Research Society at 6 sites in 2 countries.
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 6 inclusion and 15 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Spain. 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?
VAS (visual analog scale) for pain on kneeling/ability to knee (time frame: 12 months post treatment). 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 NCT02750072, which also lists 26 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 30 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.