Subtalar ArthritisISTA-ASTA RCTNCT07486596
Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis
A study testing Arthroscopic Subtalar Arthrodesis and Open In Situ Subtalar Arthrodesis in people with Subtalar Arthritis, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are: What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subtalar Arthritis
- What is being tested?
- Arthroscopic Subtalar Arthrodesis and Open In Situ Subtalar Arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinically and radiographically confirmed symptomatic subtalar arthritis (post-traumatic, primary osteoarthritis, inflammatory or cured post-infective arthritis, symptomatic talocalcaneal coalition, or isolated subtalar arthrosis secondary to pes planovalgus deformity)
- Failure of an adequate trial of non-operative treatment for a minimum of six months
- Skeletal maturity: patients aged 18 years or older
- Ability and willingness to provide written informed consent and to comply fully with the scheduled postoperative follow-up protocol
Who cannot join
- Primary subtalar arthrodesis performed for an acute, displaced intra-articular calcaneal fracture
- Arthrodesis planned in conjunction with other simultaneous ipsilateral hindfoot procedures
- Patients with open physes (skeletal immaturity)
- Indication for a distraction-type arthrodesis requiring structural bone graft
- History of previous or current active infection at the planned operative site
- Previous failed attempt at subtalar arthrodesis
- Presence of significant peripheral vascular disease or other major medical comorbidities precluding safe surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Open Versus Arthroscopic Approaches for Subtalar Arthrodesis in Patients With Subtalar Arthritis
The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are:
What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer complications?
Read more
Researchers will compare arthroscopic subtalar arthrodesis (ASTA) using a combined three-to-four portal approach to open in situ subtalar arthrodesis (ISTA) to see if one technique results in superior fusion rates, faster healing, and better functional outcomes.
Participants will:
Undergo one of two surgical procedures (either ASTA or ISTA) Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery Have X-rays taken to assess fusion and bone healing Complete pain and function questionnaires at each visit
Read the detailed description
Background and Rationale:
Subtalar arthritis is a debilitating condition frequently resulting from intra-articular calcaneal fractures, leading to progressive cartilage degeneration, hindfoot pain, and functional impairment. When conservative management fails, subtalar arthrodesis (fusion) is the established gold standard surgical treatment. Open in situ subtalar arthrodesis (ISTA) via the sinus tarsi approach has a long history of success with reported fusion rates of 85-95%. However, arthroscopic subtalar arthrodesis (ASTA) has gained popularity due to proposed advantages including preservation of blood supply, reduced soft tissue trauma, and lower wound complication rates. High-quality prospective comparative data between these two techniques remain limited.
Study Design:
Single-center, prospective, randomized controlled trial at Kasr Al-Ainy Hospitals, Cairo University. Forty patients with symptomatic subtalar arthritis are randomized 1:1 to ASTA (n=20) or ISTA (n=20) using computer-generated sequences with allocation concealment via sequentially numbered sealed opaque envelopes. Due to the nature of surgical interventions, blinding of patients and surgeons is not feasible; however, outcome assessment is performed by a blinded independent assessor.
Surgical Interventions:
Arthroscopic Subtalar Arthrodesis (ASTA): Performed under spinal anesthesia in the prone position. A combined three-to-four portal arthroscopic technique is used, including anterolateral (sinus tarsi), posterolateral, and posteromedial portals for complete visualization of the subtalar joint. Complete synovectomy and cartilage debridement until healthy bleeding subchondral bone is exposed.. Subchondral drilling creates microfractures to enhance vascular ingrowth. Fixation is achieved with two percutaneously inserted 6.5-7.3 mm cannulated screws under fluoroscopic guidance.
Open In Situ Subtalar Arthrodesis (ISTA): Performed under spinal anesthesia with the patient supine via a 4-5 cm oblique sinus tarsi approach. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance.
Postoperative Protocol:
Standardized rehabilitation: non-weight-bearing in a short-leg removable cast boot for 6 weeks, followed by progressive weight-bearing once radiographic union is confirmed. Formal physiotherapy begins after transition to full weight-bearing.
Outcome Evaluation:
Patients are assessed at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively. Primary outcomes are radiographic fusion rate and time to radiographic union (defined as trabecular bridging across the posterior facet on plain radiographs or CT). Secondary outcomes include pain (VAS), functional status (Modified AOFAS), quality of life (SF-12), operative time, blood loss, and complication rates. Subgroup analyses by age, sex, BMI, smoking status, and arthritis etiology are performed.
Statistical Analysis:
Sample size (40 patients) calculated for expected fusion rates of 100% (ASTA) vs 95% (ISTA) with non-inferiority margin of 0.15, 80% power, and two-tailed alpha 0.05. Analysis includes t-tests, chi-square tests, Kaplan-Meier survival analysis, and multivariable regression. Significance set at p < 0.05.
Ethics:
Study approved by Research Ethics Committee, Faculty of Medicine, Cairo University (13 February 2024). All patients provide written informed consent. Conducted in accordance with the Declaration of Helsinki (2013), ICMJE, and CONSORT guidelines.
- Conditions
- Subtalar Arthritis
- Being tested
- Arthroscopic Subtalar Arthrodesis, Open In Situ Subtalar Arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Subtalar ArthrodesisProcedure or surgery
Also called ASTA
Arthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance.
Open In Situ Subtalar ArthrodesisProcedure or surgery
Also called ISTA
Lateral sinus tarsi approach performed supine with 4-5 cm oblique incision. Complete cartilage debridement to bleeding cancellous bone, subchondral plate perforation, and percutaneous screw fixation (two cannulated screws) under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Subtalar Arthrodesis (ASTA) | Active comparator | Arthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance. Receives: Procedure: Arthroscopic Subtalar Arthrodesis |
| Open In Situ Subtalar Arthrodesis (ISTA) | Experimental | Open in situ subtalar arthrodesis via the lateral sinus tarsi approach performed in the supine position. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance. Receives: Procedure: Open In Situ Subtalar Arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rate at 6 months
Fusion rate is defined as the proportion of patients achieving successful solid bony union of the subtalar joint. Union is determined using combined clinical and radiographic criteria, including absence of pain on palpation and passive stress, absence of detectable subtalar motion, and presence of continuous trabecular bridging across the posterior facet on plain radiographs or computed tomography when radiographs are inconclusive.
Measured: 6 months postoperatively
Time to Radiographic Union
Time to radiographic union is defined as the time elapsed from the date of surgery to the first radiographic evidence of continuous trabecular bridging across the subtalar joint fusion interface. Assessment is performed using serial plain radiographs, with computed tomography utilized when findings are equivocal.
Measured: Up to 12 months postoperatively
Secondary outcomes (4)
Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Functional outcome is assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score (modified version, maximum 94 points excluding the subtalar motion component). The scale ranges from 0 to 94, with higher scores indicating better function. The score evaluates pain, function, and alignment. Change from baseline is compared between arthroscopic and open subtalar arthrodesis groups.
Measured: Preoperative baseline, 6 months postoperatively, and 12 months postoperatively
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity is assessed using the Visual Analog Scale (VAS), a 0 to 10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. Change from baseline is evaluated at each follow-up time point and compared between treatment groups.
Measured: Preoperative baseline, 6 weeks, 3 months, 6 months, 12 months postoperatively
Change in Short Form-12 (SF-12) Health Survey Scores
Health-related quality of life is assessed using the Short Form-12 (SF-12) Health Survey, including the Physical Component Summary (PCS) and Mental Component Summary (MCS). Each component is scored on a scale from 0 to 100, with higher scores indicating better health status. Change from baseline is compared between treatment groups.
Measured: Preoperative baseline, 6 months postoperatively, 12 months postoperatively
Complication Rate
Incidence and nature of all perioperative and postoperative complications, classified by severity including wound complications, nerve injury, hardware-related issues, non-union, malunion, and infection.
Measured: Intraoperative through 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start5 Dec 2023
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtalar ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Helal Hosny, Cairo University
- Investigators
- Helal Hosny Abdulaziz, M.B., B.Ch., M.Sc., Principal investigator, Cairo UniversityAhmed Samir Bashandy, Study chair, Cairo UniversityAhmed Mohamed Khedr, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486596
- Sponsor's protocol ID
- MD-482-2023
- Acronym
- ISTA-ASTA RCT
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Open Versus Arthroscopic Approaches for Subtalar Arthrodesis in Patients With Subtalar Arthritis
- ClinicalTrials.gov ID
- NCT07486596
- Acronym / sponsor ID
- ISTA-ASTA RCT / MD-482-2023
- Conditions
- Subtalar Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are:
What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer complications?
Researchers will compare arthroscopic subtalar arthrodesis (ASTA) using a combined three-to-four portal approach to open in situ subtalar arthrodesis (ISTA) to see if one technique results in superior fusion rates, faster healing, and better functional outcomes.
Participants will:
Undergo one of two surgical procedures (either ASTA or ISTA) Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery Have X-rays taken to assess fusion and bone healing Complete pain and function questionnaires at each visit
Detailed description
Background and Rationale:
Subtalar arthritis is a debilitating condition frequently resulting from intra-articular calcaneal fractures, leading to progressive cartilage degeneration, hindfoot pain, and functional impairment. When conservative management fails, subtalar arthrodesis (fusion) is the established gold standard surgical treatment. Open in situ subtalar arthrodesis (ISTA) via the sinus tarsi approach has a long history of success with reported fusion rates of 85-95%. However, arthroscopic subtalar arthrodesis (ASTA) has gained popularity due to proposed advantages including preservation of blood supply, reduced soft tissue trauma, and lower wound complication rates. High-quality prospective comparative data between these two techniques remain limited.
Study Design:
Single-center, prospective, randomized controlled trial at Kasr Al-Ainy Hospitals, Cairo University. Forty patients with symptomatic subtalar arthritis are randomized 1:1 to ASTA (n=20) or ISTA (n=20) using computer-generated sequences with allocation concealment via sequentially numbered sealed opaque envelopes. Due to the nature of surgical interventions, blinding of patients and surgeons is not feasible; however, outcome assessment is performed by a blinded independent assessor.
Surgical Interventions:
Arthroscopic Subtalar Arthrodesis (ASTA): Performed under spinal anesthesia in the prone position. A combined three-to-four portal arthroscopic technique is used, including anterolateral (sinus tarsi), posterolateral, and posteromedial portals for complete visualization of the subtalar joint. Complete synovectomy and cartilage debridement until healthy bleeding subchondral bone is exposed.. Subchondral drilling creates microfractures to enhance vascular ingrowth. Fixation is achieved with two percutaneously inserted 6.5-7.3 mm cannulated screws under fluoroscopic guidance.
Open In Situ Subtalar Arthrodesis (ISTA): Performed under spinal anesthesia with the patient supine via a 4-5 cm oblique sinus tarsi approach. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance.
Postoperative Protocol:
Standardized rehabilitation: non-weight-bearing in a short-leg removable cast boot for 6 weeks, followed by progressive weight-bearing once radiographic union is confirmed. Formal physiotherapy begins after transition to full weight-bearing.
Outcome Evaluation:
Patients are assessed at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively. Primary outcomes are radiographic fusion rate and time to radiographic union (defined as trabecular bridging across the posterior facet on plain radiographs or CT). Secondary outcomes include pain (VAS), functional status (Modified AOFAS), quality of life (SF-12), operative time, blood loss, and complication rates. Subgroup analyses by age, sex, BMI, smoking status, and arthritis etiology are performed.
Statistical Analysis:
Sample size (40 patients) calculated for expected fusion rates of 100% (ASTA) vs 95% (ISTA) with non-inferiority margin of 0.15, 80% power, and two-tailed alpha 0.05. Analysis includes t-tests, chi-square tests, Kaplan-Meier survival analysis, and multivariable regression. Significance set at p < 0.05.
Ethics:
Study approved by Research Ethics Committee, Faculty of Medicine, Cairo University (13 February 2024). All patients provide written informed consent. Conducted in accordance with the Declaration of Helsinki (2013), ICMJE, and CONSORT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Subtalar Arthrodesis (ASTA) | Active comparator | Procedure: Arthroscopic Subtalar ArthrodesisArthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance. |
| Open In Situ Subtalar Arthrodesis (ISTA) | Experimental | Procedure: Open In Situ Subtalar ArthrodesisOpen in situ subtalar arthrodesis via the lateral sinus tarsi approach performed in the supine position. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically and radiographically confirmed symptomatic subtalar arthritis (post-traumatic, primary osteoarthritis, inflammatory or cured post-infective arthritis, symptomatic talocalcaneal coalition, or isolated subtalar arthrosis secondary to pes planovalgus deformity)
- Failure of an adequate trial of non-operative treatment for a minimum of six months
- Skeletal maturity: patients aged 18 years or older
- Ability and willingness to provide written informed consent and to comply fully with the scheduled postoperative follow-up protocol
Key exclusion criteria (7 listed)
- Primary subtalar arthrodesis performed for an acute, displaced intra-articular calcaneal fracture
- Arthrodesis planned in conjunction with other simultaneous ipsilateral hindfoot procedures
- Patients with open physes (skeletal immaturity)
- Indication for a distraction-type arthrodesis requiring structural bone graft
- History of previous or current active infection at the planned operative site
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 |
|---|---|---|
| Arthroscopic Subtalar ArthrodesisAlso: ASTAArthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance. | Procedure or surgery | Arthroscopic Subtalar Arthrodesis (ASTA) |
| Open In Situ Subtalar ArthrodesisAlso: ISTALateral sinus tarsi approach performed supine with 4-5 cm oblique incision. Complete cartilage debridement to bleeding cancellous bone, subchondral plate perforation, and percutaneous screw fixation (two cannulated screws) under fluoroscopic guidance. | Procedure or surgery | Open In Situ Subtalar Arthrodesis (ISTA) |
Primary outcome
Fusion Rate at 6 months
Time frame: 6 months postoperatively
Fusion rate is defined as the proportion of patients achieving successful solid bony union of the subtalar joint. Union is determined using combined clinical and radiographic criteria, including absence of pain on palpation and passive stress, absence of detectable subtalar motion, and presence of continuous trabecular bridging across the posterior facet on plain radiographs or computed tomography when radiographs are inconclusive.
Time to Radiographic Union
Time frame: Up to 12 months postoperatively
Time to radiographic union is defined as the time elapsed from the date of surgery to the first radiographic evidence of continuous trabecular bridging across the subtalar joint fusion interface. Assessment is performed using serial plain radiographs, with computed tomography utilized when findings are equivocal.
4 secondary outcomes
Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time frame: Preoperative baseline, 6 months postoperatively, and 12 months postoperatively
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Preoperative baseline, 6 weeks, 3 months, 6 months, 12 months postoperatively
Change in Short Form-12 (SF-12) Health Survey Scores
Time frame: Preoperative baseline, 6 months postoperatively, 12 months postoperatively
Complication Rate
Time frame: Intraoperative through 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Subtalar Arthritis
Recruiting
Primary Subtalar Arthrodesis for Calcaneal Fractures
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Not yet recruitingObservational study
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
Ankle Arthritis
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.
Helal Hosny Abdulaziz, M.B., B.Ch., M.Sc. principal investigator
Cairo University
Ahmed Samir Bashandy study chair
Cairo University
Ahmed Mohamed Khedr study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Subtalar Arthrodesis and Open In Situ Subtalar Arthrodesis in people with Subtalar Arthritis, run by Cairo University at 1 site in Egypt.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fusion Rate at 6 months (time frame: 6 months postoperatively). 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?
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 13 Apr 2026.