Arthropathy of Shoulder RegionNCT03726554

Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

A study testing Comprehensive Reverse Porous Augmented Glenoid and Comprehensive Mini Humeral Tray in people with Arthropathy of Shoulder Region and Grossly Deficient Rotator Cuff, run by Zimmer Biomet at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder
What is being tested?: Comprehensive Reverse Porous Augmented Glenoid and Comprehensive Mini Humeral Tray
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 6 sitesUnited States
Study dates: 28 Aug 2018to Feb 2030
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

Patient must be 18 years of age or older.
Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Patient must be able and willing to complete the protocol required follow-up.
Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.

Who cannot join

Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
Patient presents with osteoporosis.
Patient has a metabolic disorder that may impair bone formation.
Patient has osteomalacia.
Patient has distant foci of infections which may spread to the implant site.
Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

The Research Foundation for the State University of New York
Buffalo, New York, 14215
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, 22903
Campbell Foundation
Germantown, Tennessee, 38138
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
Norton Orthopedic Specialists
Louisville, Kentucky, 40241
William Beaumont Hospital
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study

Read the detailed description

The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain.

A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.

Conditions: Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthritis
Being tested: Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
Keywords: Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comprehensive Reverse Porous Augmented GlenoidDevice
Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.
Comprehensive Mini Humeral TrayDevice
The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.

Study groups in NCT03726554
Study group	Role	What they receive
Comp. Rev. Porous Augmented Glenoid	Experimental	Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid. Receives: Device: Comprehensive Reverse Porous Augmented Glenoid
Comp. Rev. Mini Humeral Tray	Experimental	Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray Receives: Device: Comprehensive Mini Humeral Tray

What is being measured

The primary outcome is the main question the study is designed to answer.

Implant Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Measured: 10 years

Secondary outcomes (3)

Frequency and Incidence of Adverse Events
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Measured: 10 years
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.
Pain, function, and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Measured: 10 years
Radiographic Performance
X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 2018Feb 2030

First posted31 Oct 2018
Study start28 Aug 2018
Primary completionFeb 2030 (estimated)
Study completionFeb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthropathy of Shoulder RegionStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03726554
Sponsor's protocol ID: CMG2017-70E
Status last verified: Jul 2026
First submitted: 26 Sep 2018
Last updated: 9 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
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Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, Ansd Function
Shoulder Pain and Stiffness
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder

All Arthropathy of Shoulder Region trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
ClinicalTrials.gov ID: NCT03726554
Acronym / sponsor ID: CMG2017-70E
Conditions: Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthritis
Keywords: Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 99 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 28 Aug 2018 (actual)
Primary completion: Feb 2030 (estimated)
Study completion: Feb 2030 (estimated)
First posted: 31 Oct 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Comp. Rev. Porous Augmented Glenoid	Experimental	Device: Comprehensive Reverse Porous Augmented GlenoidSubjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.
Comp. Rev. Mini Humeral Tray	Experimental	Device: Comprehensive Mini Humeral TraySubjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient must be 18 years of age or older.
Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Patient must be able and willing to complete the protocol required follow-up.
Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.

Key exclusion criteria (8 listed)

Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
Patient presents with osteoporosis.
Patient has a metabolic disorder that may impair bone formation.

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
Comprehensive Reverse Porous Augmented GlenoidThree glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.	Device	Comp. Rev. Porous Augmented Glenoid
Comprehensive Mini Humeral TrayThe mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.	Device	Comp. Rev. Mini Humeral Tray

Primary outcome

Implant Survivorship
Time frame: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method

3 secondary outcomes

Frequency and Incidence of Adverse Events
Time frame: 10 years
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.
Time frame: 10 years
Radiographic Performance
Time frame: 10 years

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 9 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Arthropathy of Shoulder Region

Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Active, not recruiting
Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, Ansd Function
Shoulder Pain and Stiffness
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder

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.

Hillary Overholser study director

Zimmer Biomet

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Implant Survivorship (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726554.

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 9 Jul 2026.