Rotator Cuff TearsNCT06016439
Outcomes of Massive Rotator Cuff Tendon Tear Treatment.
A study testing Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT, Arthroscopic rotator cuff partial repair and Arthroscopic complete rotator cuff repair in people with Rotator Cuff Tears and Rotator Cuff Syndrome, run by Tartu University Hospital.
Trial summary
Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Syndrome
- What is being tested?
- Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT, Arthroscopic rotator cuff partial repair and Arthroscopic complete rotator cuff repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2033
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.
- Primary rotator cuff pathology AND
- Symptoms have not lasted more than 6 months.
- In case of trauma, traumatic event no more than 6 months ago.
- Aged between 50 and 80 at the time of enrollment.
- Subject is able and willing to give informed consent AND
- Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits.
Who cannot join
- Previous rotator cuff surgery of the index shoulder.
- Acute or chronic osteomyelitis.
- Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).
- Uncontrolled diabetes.
- Active oncological disease.
- Radiologically stage IV shoulder joint arthrosis (rotator cuff arthropathy).
Show all 12Show fewer
- Systemic or intra-articular corticosteroid therapy less than 60 days prior to planned operation date.
- Intramuscular or peroral corticosteroid treatment less than 30 days prior to planned operation date.
- Acute or chronic conditions that are contraindications for functional testing.
- MRI contraindicated.
- Substance or alcohol abuse.
- Refusal or withdrawal of consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Madis Rahu, PhD/MD contact
About this study
Official title: Outcomes of Different Treatment Modalities for Massive Rotator Cuff Tendon Tear.
Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence.
This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group.
The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.
Read the detailed description
Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included in the study following the eligibility criteria. Massive tear is defined as grade III tear according to Davidson and Burkhart classification (2010), supraspinatus (SSP) tendon retraction described by Patte (1990) classification.
The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator cuff repair procedures will be done by three orthopaedic surgeons with long experience in arthroscopic shoulder surgery.
It is determined intra-operatively whether the tear is reparable or not. If possible, the tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn randomization takes place - either partial repair or partial repair with SCR using the LHBB tendon. Surgical techniques will be standardized. Patients who refuse operative treatment, will be followed as conservative treatment group.
The primary objective of the study is the functional status of the included subjects in different treatment groups. The secondary objective of the study is to confirm whether the tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24 months after operation using Sugaya classification (2007).
The post-operative therapy regimen will be the same for each study group. Subjects will come for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist of range of motion (ROM), strength measurements, preoperative radiography measuring acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH), The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK) score. Goutallier classification (1994) will be used pre- and postoperatively to measure muscle fatty infiltration.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Syndrome
- Being tested
- Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT, Arthroscopic rotator cuff partial repair, Arthroscopic complete rotator cuff repair, Suture anchor(s)
- Keywords
- rotator cuff injury, rotator cuff tears, massive, shoulder, shoulder injuries, superior capsular reconstruction, long head of biceps tendon, irreparable, tear, rupture, partial repair
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Injuries, Lacerations, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBTProcedure or surgery
Residual rotator cuff defect will be reconstructed using LHBBT.
Arthroscopic rotator cuff partial repairProcedure or surgery
Rotator cuff will be repaired with remaining residual defect.
Arthroscopic complete rotator cuff repairProcedure or surgery
Arthroscopic complete repair as a standard procedure.
Suture anchor(s)Device
Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT | Experimental | If a tear is intra-operatively determined irreparable, randomization takes place.
Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity. Receives: Procedure: Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT; Device: Suture anchor(s) |
| Arthroscopic partial rotator cuff repair | Active comparator | If a tear is intra-operatively determined irreparable, randomization takes place.
Irreparable tears that are randomly selected to receive arthroscopic partial repair. Receives: Procedure: Arthroscopic rotator cuff partial repair; Device: Suture anchor(s) |
| Arthroscopic rotator cuff repair | Other | Arthroscopic complete repair. Receives: Procedure: Arthroscopic complete rotator cuff repair; Device: Suture anchor(s) |
| Rotator cuff tear conservative treatment | No intervention | Conservative treatment following physiotherapy protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder strength
Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in shoulder range of motion.
Measured by the change in shoulder range of motion (abduction, internal and external rotation).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.
Measured by the change in joint functional score.
The higher the score, the better the outcome.
The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008).
The pASES form has 3 sections: pain, instability, activities of daily living (ADLs) (Goldhahn, 2008).
Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain).
Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).
Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the Constant-Murley score (CMS).
Measured by the change in joint functional score.
The higher the score, the higher the quality of the function.
The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).
Measured by the change in joint functional score.
The higher the score, the more severe disability.
30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity.
Total scores range from 0 (minimum) to (100) maximum.
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in pain score
Measured by the change in pain score according to the visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Secondary outcomes (3)
Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).
Integrity of surgically repaired rotator cuff tendons on post-operative MRI studies.
Classified into five categories (from intact tendon to full tear):
Type I: sufficient thickness with homogeneously low intensity; Type II: sufficient thickness with partial high intensity; Type III: insufficient thickness without discontinuity; Type IV: the presence of a minor discontinuity; Type V: the presence of a major discontinuity.
Measured: postoperatively 6 months, 12 months and 24 months
Change in quality of life
Measured by the change in score according to EEK-2 (emotsionaalse enesetunde küsimustik, Emotional State Questionnaire) score.
The higher the score, the higher the risk of having emotional state disabilities.
The overall score ranges from 0-112, but it is divided into six categories that are assessed separately.
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in kinesiophobia score
Change in kinesiophobia score according to Tampa Scale for Kinesiophobia.
The higher the score, the higher the degree of kinesiophobia.
Results consist of a total raw score (range between 17 and 68) and two subscale scores (activity avoidance and somatic focus).
Measured: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Sponsor
- Investigators
- Tiina Tikk, MD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016439
- Sponsor's protocol ID
- Tikk23
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2023
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Different Treatment Modalities for Massive Rotator Cuff Tendon Tear.
- ClinicalTrials.gov ID
- NCT06016439
- Acronym / sponsor ID
- Tikk23
- Conditions
- Rotator Cuff Tears, Rotator Cuff Syndrome
- Keywords
- rotator cuff injury, rotator cuff tears, massive, shoulder, shoulder injuries, superior capsular reconstruction, long head of biceps tendon, irreparable
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 29 Aug 2023 (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.
Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence.
This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group.
The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.
Detailed description
Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included in the study following the eligibility criteria. Massive tear is defined as grade III tear according to Davidson and Burkhart classification (2010), supraspinatus (SSP) tendon retraction described by Patte (1990) classification.
The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator cuff repair procedures will be done by three orthopaedic surgeons with long experience in arthroscopic shoulder surgery.
It is determined intra-operatively whether the tear is reparable or not. If possible, the tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn randomization takes place - either partial repair or partial repair with SCR using the LHBB tendon. Surgical techniques will be standardized. Patients who refuse operative treatment, will be followed as conservative treatment group.
The primary objective of the study is the functional status of the included subjects in different treatment groups. The secondary objective of the study is to confirm whether the tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24 months after operation using Sugaya classification (2007).
The post-operative therapy regimen will be the same for each study group. Subjects will come for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist of range of motion (ROM), strength measurements, preoperative radiography measuring acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH), The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK) score. Goutallier classification (1994) will be used pre- and postoperatively to measure muscle fatty infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT | Experimental | Procedure: Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT, Device: Suture anchor(s)If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity. |
| Arthroscopic partial rotator cuff repair | Active comparator | Procedure: Arthroscopic rotator cuff partial repair, Device: Suture anchor(s)If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic partial repair. |
| Arthroscopic rotator cuff repair | Other | Procedure: Arthroscopic complete rotator cuff repair, Device: Suture anchor(s)Arthroscopic complete repair. |
| Rotator cuff tear conservative treatment | No intervention | –Conservative treatment following physiotherapy protocol. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.
- Primary rotator cuff pathology AND
- Symptoms have not lasted more than 6 months.
- In case of trauma, traumatic event no more than 6 months ago.
- Aged between 50 and 80 at the time of enrollment.
Key exclusion criteria (12 listed)
- Previous rotator cuff surgery of the index shoulder.
- Acute or chronic osteomyelitis.
- Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).
- Uncontrolled diabetes.
- Active oncological disease.
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 rotator cuff partial repair with superior capsular augmentation with LHBBTResidual rotator cuff defect will be reconstructed using LHBBT. | Procedure or surgery | Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT |
| Arthroscopic rotator cuff partial repairRotator cuff will be repaired with remaining residual defect. | Procedure or surgery | Arthroscopic partial rotator cuff repair |
| Arthroscopic complete rotator cuff repairArthroscopic complete repair as a standard procedure. | Procedure or surgery | Arthroscopic rotator cuff repair |
| Suture anchor(s)Arthroscopic rotator cuff tendon(s) repair using suture anchor(s). | Device | Arthroscopic partial rotator cuff repair, Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT, Arthroscopic rotator cuff repair |
Primary outcome
Change in shoulder strength
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).
Change in shoulder range of motion.
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in shoulder range of motion (abduction, internal and external rotation).
Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in joint functional score. The higher the score, the better the outcome. The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008). The pASES form has 3 sections: pain, instability, activities of daily living (ADLs) (Goldhahn, 2008). Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain). Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)). Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).
Functional outcome according to the Constant-Murley score (CMS).
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in joint functional score. The higher the score, the higher the quality of the function. The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in joint functional score. The higher the score, the more severe disability. 30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity. Total scores range from 0 (minimum) to (100) maximum.
Change in pain score
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Measured by the change in pain score according to the visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain).
3 secondary outcomes
Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).
Time frame: postoperatively 6 months, 12 months and 24 months
Change in quality of life
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in kinesiophobia score
Time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
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 24 Nov 2023.
- 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.
Madis Rahu, PhD/MD contact
Tiina Tikk, MD principal investigator
University of Tartu
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT, Arthroscopic rotator cuff partial repair and Arthroscopic complete rotator cuff repair in people with Rotator Cuff Tears and Rotator Cuff Syndrome, run by Tartu University Hospital.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Tiina Tikk, MD (55929399 ext. +372, tiinatikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shoulder strength (time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit). The study lists 6 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 24 Nov 2023.