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

• ClinicalTrials.gov Identifier: NCT03726554
• Recruitment Status: Active, not recruiting
• First Posted: October 31, 2018
• Last Update Posted: August 7, 2020
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

Brief 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 Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.

Condition or disease	Intervention/treatment
Arthropathy of Shoulder Region; Grossly Deficient Rotator Cuff; Osteoarthritis of the Shoulder; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Post-Traumatic Arthritis	Device: Comprehensive Reverse Porous Augmented Glenoid; Device: Comprehensive Mini Humeral Tray

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
• Actual Study Start Date: August 28, 2018
• Estimated Primary Completion Date: February 2030
• Estimated Study Completion Date: February 2030

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Implant Survivorship [ Time Frame: 10 years ]
   Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Secondary Outcome Measures :

1. Frequency and Incidence of Adverse Events [ Time Frame: 10 years ]
   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.
2. Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire. [ Time Frame: 10 years ]
   Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
3. Radiographic Performance [ Time Frame: 10 years ]
   X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of a reverse shoulder arthroplasty who receive a Comprehensive Reverse Porous Augmented Glenoid and/or Comprehensive Mini Humeral Tray who meet all of the inclusion and none of the exclusion criteria.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Florida

Andrews Research and Education Foundation

Gulf Breeze, Florida, United States, 32561

United States, Kentucky

Norton Orthopedic Specialists

Louisville, Kentucky, United States, 40241

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, New York

The Research Foundation for the State University of New York

Buffalo, New York, United States, 14215

United States, Tennessee

Campbell Foundation

Germantown, Tennessee, United States, 38138

United States, Virginia

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Kacy Arnold, RN, MBA; Zimmer Biomet

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT03726554
• Other Study ID Numbers: CMG2017-70E
• First Posted: October 31, 2018
• Last Update Posted: August 7, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Zimmer Biomet:

Reverse Shoulder Arthroplasty; Medical Device; Performance; Safety; Shoulder Prosthesis; Glenoid Erosion

Additional relevant MeSH terms:

Arthritis; Joint Diseases; Musculoskeletal Diseases