Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

January 15, 2026 updated by: Dr. Alex Martusiewicz, Corewell Health East

Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial

The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing primary reverse total shoulder arthroplasty with the following components:

    1. Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
    2. Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
  • Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
  • Negative external rotation lag sign, ability to externally rotate beyond neutral
  • Age 18 years or older

Exclusion Criteria:

  • Revision arthroplasty
  • Prior open shoulder surgery
  • Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
  • Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
  • Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention
  • Patient anatomy does not accommodate the study implants per surgeon discretion
  • Pregnant, patient-reported
  • Minors (under 18 years of age)
  • Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Onlay Component-Tornier Ascend Flex stem
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Device: Tornier Ascend Flex stem
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Active Comparator: Inlay Component-Tornier Perform Stem Reverse+
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
Device: Tornier Perform Stem Reverse+
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Active external rotation, 2 years
Time Frame: 2 years postoperative
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
2 years postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Active external rotation, 3 months
Time Frame: 3 months postoperative
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
3 months postoperative
Active external rotation, 1 year
Time Frame: 1 year postoperative
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
1 year postoperative
Strength during active external rotation, 3 months
Time Frame: 3 months postoperative
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
3 months postoperative
Strength during active external rotation, 1 year
Time Frame: 1 year postoperative
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
1 year postoperative
Strength during active external rotation, 2 years
Time Frame: 2 years postoperative
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds
2 years postoperative
Active forward elevation, 3 months
Time Frame: 3 months postoperative
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
3 months postoperative
Active forward elevation, 1 year
Time Frame: 1 year postoperative
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
1 year postoperative
Active forward elevation, 2 years
Time Frame: 2 years postoperative
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
2 years postoperative
Strength during active forward elevation, 3 months
Time Frame: 3 months postoperative
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
3 months postoperative
Strength during active forward elevation, 1 year
Time Frame: 1 year postoperative
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
1 year postoperative
Strength during active forward elevation, 2 years
Time Frame: 2 years postoperative
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
2 years postoperative
Abduction, 3 months
Time Frame: 3 months postoperative
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
3 months postoperative
Abduction, 1 year
Time Frame: 1 year postoperative
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
1 year postoperative
Abduction, 2 years
Time Frame: 2 years postoperative
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
2 years postoperative
Strength during abduction, 3 months
Time Frame: 3 months postoperative
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
3 months postoperative
Strength during abduction, 1 year
Time Frame: 1 year postoperative
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
1 year postoperative
Strength during abduction, 2 years
Time Frame: 2 years postoperative
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
2 years postoperative
Internal rotation, 3 months
Time Frame: 3 months postoperative
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
3 months postoperative
Internal rotation, 1 year
Time Frame: 1 year postoperative
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
1 year postoperative
Internal rotation, 2 years
Time Frame: 2 years postoperative
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
2 years postoperative
Strength during Internal rotation, 3 months
Time Frame: 3 months postoperative
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
3 months postoperative
Strength during Internal rotation, 1 year
Time Frame: 1 year postoperative
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
1 year postoperative
Strength during Internal rotation, 2 years
Time Frame: 2 years postoperative
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
2 years postoperative
External rotation lag sign test, 3 months
Time Frame: 3 months postoperative
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
3 months postoperative
External rotation lag sign test, 1 year
Time Frame: 1 year postoperative
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
1 year postoperative
External rotation lag sign test, 2 years
Time Frame: 2 years postoperative
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally A positive test indicates supraspinatus and infraspinatus tendon weakness.
2 years postoperative
Drop arm test, 3 months
Time Frame: 3 months postoperative
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
3 months postoperative
Drop arm test, 1 year
Time Frame: 1 year postoperative
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
1 year postoperative
Drop arm test, 2 years
Time Frame: 2 years postoperative
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
2 years postoperative
Lift off test, 3 months
Time Frame: 3 months postoperative
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
3 months postoperative
Lift off test, 1 year
Time Frame: 1 year postoperative
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
1 year postoperative
Lift off test, 2 years
Time Frame: 2 years postoperative
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
2 years postoperative
Belly press test, 3 months
Time Frame: 3 months postoperative
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
3 months postoperative
Belly press test, 1 year
Time Frame: 1 year postoperative
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
1 year postoperative
Belly press test, 2 years
Time Frame: 2 years postoperative
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
2 years postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
Time Frame: 3 months postoperative
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
3 months postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
Time Frame: 1 year postoperative
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
1 year postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
Time Frame: 2 years postoperative
Patients will complete a questionnaire of shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
2 years postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
Time Frame: 3 months postoperative
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
3 months postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
Time Frame: 1 year postoperative
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
1 year postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years
Time Frame: 2 years postoperative
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
2 years postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months
Time Frame: 3 months postoperative
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
3 months postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year
Time Frame: 1 year postoperative
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
1 year postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years
Time Frame: 2 years postoperative
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
2 years postoperative
Visual Analog Scale measure of pain, 3 months
Time Frame: 3 months postoperative
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
3 months postoperative
Visual Analog Scale measure of pain, 1 year
Time Frame: 1 year postoperative
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
1 year postoperative
Visual Analog Scale measure of pain, 2 years
Time Frame: 2 years postoperative
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
2 years postoperative
Scapular notching, 3 months
Time Frame: 3 months postoperative
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
3 months postoperative
Scapular notching, 1 year
Time Frame: 1 year postoperative
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
1 year postoperative
Scapular notching, 2 years
Time Frame: 2 years postoperative
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
2 years postoperative
Reoperation
Time Frame: 2 years postoperative
Number of patients requiring reoperation of the same shoulder within 2 years.
2 years postoperative
Study-related adverse events
Time Frame: 2 years postoperative
All adverse events determined by the PI to be probably or definitely related to study interventions (surgery or device).
2 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corewell Health East

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Nordic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alex Martusiewicz, MD, Beaumont Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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