Anterior Cruciate Ligament (ACL) ReconstructionNCT07475351
Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction
A study testing Bone-Patellar tendon-Bone and Patellar tendon-Bone in people with Anterior Cruciate Ligament (ACL) Reconstruction and Anterior Cruciate Ligament Injury, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament Injury
- What is being tested?
- Bone-Patellar tendon-Bone and Patellar tendon-Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to Mar 2028
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Time for injury to surgery of less than six months.
- Active athletes (federated or recreational)
- Patellar tendon length > 42mm measured by MRI.
- Age between 12 and 40 years old
- Genders eligible for Study: both
Who cannot join
- Previous surgery or history of ligamentous knee injuries.
- Concomitant knee ligament injury
- Major meniscal injury (more than 50% of the lateral or medial meniscus)
- Chondral injury greater than Outerbridge Grade I-II
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Health Sciences Faculty, University of Granada
Granada, Granada, 18016
Jose M Rodriguez-Delgado, +34664807986, josemariard@ugr.es
Manuel Arroyo-Morales
About this study
Official title: Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:
- Does PT graft reduce donor site morbidity compared to the standard BPTB graft?
- Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.
Read more
Patients will:
- Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)
- Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
Read the detailed description
Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.
Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.
The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.
- Being tested
- Bone-Patellar tendon-Bone, Patellar tendon-Bone
- Keywords
- ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, BONE PATELLAR TENDON BONE, PATELLAR TENDON
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-Patellar tendon-BoneProcedure or surgery
After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal.
Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:
- Minimum length: 42mm
- Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.
- Bone plugs: patellar and tibial bone plugs (10x20x8mm) are harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique.
Patellar tendon-BoneProcedure or surgery
Also called Patellar tendon
After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal.
Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:
- Minimum length: 42mm
- Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.
- Bone plugs: a tibial bone plug (10x20x8mm) is harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique.
| Study group | Role | What they receive |
|---|---|---|
| Patellar tendon - Bone (PT) | Active comparator | Not described Receives: Procedure: Patellar tendon-Bone |
| Bone - Patellar tendon - Bone (BPTB) | Active comparator | Not described Receives: Procedure: Bone-Patellar tendon-Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor Site Morbidity
Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications).
Measured: At 3, 8, 12 and 24 months after surgery
Secondary outcomes (19)
Function and activity level
Lysholm-Tegner score will be used to report knee function and activity level. Scores range from 0 to 100 points, where 100 indicates a better outcome (knee function).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Subjective knee status
International Knee Documentation Committee (IKDC) will be used to assess knee signs and symptoms. Total scores range from 0 to 100 points, where a higher score indicates a better outcome (absence of symptoms and maximum functional level).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Psychological readiness
Anterior cruciate ligament - Return to Sport after Injury (ACL-RSI) Scale will be used to evaluate psychological readiness of patients to return to sport after ACL reconstruction. Scores range from 0 to 100 points, where a higher score indicates better outcome (full psychological readiness and confidence).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Joint Awareness
Forgotten Joint Score (FJS) will be used to assessthe patient's ability to forget their affected joint during activities. Scores range from 0 to 100 points, where higher scores indicate a better outcome (patients "forget" the joint, representing a natural feel).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Patient-reported symptoms
Cincinnati Knee Rating System will be used to ievaluate patient-reported symptoms. scores range from 0 to 100 points, where a higher score (100) indicates better outcome (excellent clinical result, no symptoms, and full return to sports).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Quadriceps strength
Isokinetic test will be used to evaluate quadriceps peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Hamstrings strength
Isokinetic test will be used to evaluate hamstrings peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Hamstring/Quadriceps ratio
HQ ratio will be calculated with hamstring and quadriceps peak torque from isokinetic tests.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Functional Hop Test Battery
A series of four hop tests will be performed to measure dynamic stability and neuromuscular control. Distance and limb symmetry index will be registered.
Measured: Baseline (Pre-intervention) and 8, 12 and 24 months after surgery
Donor-site pain pressure threshold
Pain pressure threshold measured via digital algometry will be used at the patellar tendon.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Quadriceps thickness
An ultrasound system with a linear probe will be used to measure quadriceps thickness.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Patellar tendon morphology
An ultrasound system with a linear probe will be used to measure patellar tendon thickness and cross-sectional area.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Anteroposterior knee stability
A Lachmeter system will be used to evaluate anteroposterior knee stability
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Knee stability
A KIRA system will be used to evaluate anteroposterior and rotational knee stability
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Height
A tallimeter will be used to register height, expressed in meters (m).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Weight
Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring weight, expressed in kilograms (kg).
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Body Mass Index (BMI)
Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring BMI, expressed in kg/m^2.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Percentage of Body Fat
Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring PBF, expressed in %.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Skeletal Muscle Mass
Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring SMM, expressed in kg.
Measured: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) ReconstructionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M Rodriguez-Delgado, Universidad de Granada
- Investigators
- Manuel Arroyo-Morales, Study chair, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475351
- Sponsor's protocol ID
- P36/24/01
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes
- ClinicalTrials.gov ID
- NCT07475351
- Acronym / sponsor ID
- P36/24/01
- Keywords
- ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, BONE PATELLAR TENDON BONE, PATELLAR TENDON
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 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 purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:
- Does PT graft reduce donor site morbidity compared to the standard BPTB graft?
- Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.
Patients will:
- Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)
- Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
Detailed description
Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.
Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.
The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar tendon - Bone (PT) | Active comparator | Procedure: Patellar tendon-Bone |
| Bone - Patellar tendon - Bone (BPTB) | Active comparator | Procedure: Bone-Patellar tendon-Bone |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Time for injury to surgery of less than six months.
- Active athletes (federated or recreational)
- Patellar tendon length > 42mm measured by MRI.
- Age between 12 and 40 years old
- Genders eligible for Study: both
Key exclusion criteria (4 listed)
- Previous surgery or history of ligamentous knee injuries.
- Concomitant knee ligament injury
- Major meniscal injury (more than 50% of the lateral or medial meniscus)
- Chondral injury greater than Outerbridge Grade I-II
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 |
|---|---|---|
| Bone-Patellar tendon-BoneAfter an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length: 42mm * Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained. * Bone plugs: patellar and tibial bone plugs (10x20x8mm) are harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique. | Procedure or surgery | Bone - Patellar tendon - Bone (BPTB) |
| Patellar tendon-BoneAlso: Patellar tendonAfter an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length: 42mm * Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained. * Bone plugs: a tibial bone plug (10x20x8mm) is harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique. | Procedure or surgery | Patellar tendon - Bone (PT) |
Primary outcome
Donor Site Morbidity
Time frame: At 3, 8, 12 and 24 months after surgery
Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications).
19 secondary outcomes
Function and activity level
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Subjective knee status
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Psychological readiness
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Joint Awareness
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Patient-reported symptoms
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Quadriceps strength
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Hamstrings strength
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Hamstring/Quadriceps ratio
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Functional Hop Test Battery
Time frame: Baseline (Pre-intervention) and 8, 12 and 24 months after surgery
Donor-site pain pressure threshold
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Quadriceps thickness
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Patellar tendon morphology
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Anteroposterior knee stability
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Knee stability
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Height
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Weight
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Body Mass Index (BMI)
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Percentage of Body Fat
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
Skeletal Muscle Mass
Time frame: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery
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 23 Mar 2026.
- 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.
Manuel Arroyo-Morales study chair
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-Patellar tendon-Bone and Patellar tendon-Bone in people with Anterior Cruciate Ligament (ACL) Reconstruction and Anterior Cruciate Ligament Injury, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Mar 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 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?
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?
Contact Jose M Rodriguez-Delgado (+34664807986, josemariard@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor Site Morbidity (time frame: At 3, 8, 12 and 24 months after surgery). 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 23 Mar 2026.