Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Post-Traumatic Arthritis, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
Conditions
Keywords
Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
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.
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.
Interventions
DEVICEComprehensive 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.
DEVICEComprehensive 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.
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship | 10 years | Based on removal or intended removal of the device and determined using the Kaplan-Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORHillary Overholser
Zimmer Biomet
Outcome results
None listed