Back to resultsPost-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Primary Purpose
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Reverse Porous Augmented Glenoid
Comprehensive Mini Humeral Tray
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Shoulder Region focused on measuring Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
Eligibility 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.
Sites / Locations
- Andrews Research and Education Foundation
- Norton Orthopedic Specialists
- William Beaumont Hospital
- The Research Foundation for the State University of New York
- Campbell Foundation
- The Rector and Visitors of the University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Comp. Rev. Porous Augmented Glenoid
Comp. Rev. Mini Humeral Tray
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Implant Survivorship
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
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.
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
X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03726554
Brief Title
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Official Title
Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
February 2030 (Anticipated)
Study Completion Date
February 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comp. Rev. Porous Augmented Glenoid
Arm Type
Experimental
Arm Description
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.
Arm Title
Comp. Rev. Mini Humeral Tray
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Comprehensive Reverse Porous Augmented Glenoid
Intervention Description
Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.
Intervention Type
Device
Intervention Name(s)
Comprehensive Mini Humeral Tray
Intervention Description
The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.
Primary Outcome Measure Information:
Title
Implant Survivorship
Description
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Frequency and Incidence of Adverse Events
Description
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.
Time Frame
10 years
Title
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.
Description
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.
Time Frame
10 years
Title
Radiographic Performance
Description
X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Osborn
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Andrews Research and Education Foundation
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Norton Orthopedic Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
The Research Foundation for the State University of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Campbell Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The Rector and Visitors of the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
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