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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03726554

Collaborator

(none)

102

Enrollment

Locations

137.2

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	Phase
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 :

Aug 28, 2018

Anticipated Primary Completion Date :

Feb 1, 2030

Anticipated Study Completion Date :

Feb 1, 2030

Arms and Interventions

Arm	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.

Arm

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

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

Secondary Outcome Measures

Frequency and Incidence of Adverse Events [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.
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire. [10 years]
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.
Radiographic Performance [10 years]
X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Andrews Research and Education Foundation	Gulf Breeze	Florida	United States	32561
2	Norton Orthopedic Specialists	Louisville	Kentucky	United States	40241
3	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
4	The Research Foundation for the State University of New York	Buffalo	New York	United States	14215
5	Campbell Foundation	Germantown	Tennessee	United States	38138
6	The Rector and Visitors of the University of Virginia	Charlottesville	Virginia	United States	22903