Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03726554|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2018
Last Update Posted : August 7, 2020
|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|
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 Type :||Observational|
|Actual Enrollment :||102 participants|
|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|
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.
- Implant Survivorship [ Time Frame: 10 years ]Based on removal or intended removal of the device and determined using the Kaplan-Meier method
- 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.
- 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.
- Radiographic Performance [ Time Frame: 10 years ]X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726554
|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|
|Germantown, Tennessee, United States, 38138|
|United States, Virginia|
|The Rector and Visitors of the University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Study Director:||Kacy Arnold, RN, MBA||Zimmer Biomet|