NCT03726554Active, not recruiting
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 26 Sept 2018
- Start date
- Aug 2018
- Primary completion date
- Feb 2030
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03726554
What you commit to
- Study type: Interventional
- Participants enrolled: 99
- From Aug 2018 to the primary completion date, Feb 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is a current alcohol or drug abuser.
Other illness
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient has a metabolic disorder that may impair bone formation.
- Patient has distant foci of infections which may spread to the implant site.
Other
- Patient is a prisoner.
- Patient presents with osteoporosis.
- Patient has osteomalacia.
- Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Research Foundation for the State University of New York Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| The Rector and Visitors of the University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Campbell Foundation Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Andrews Research and Education Foundation Coordinator of this site? Confirm its status | Gulf Breeze | United States | Unknown status |
| Norton Orthopedic Specialists Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| William Beaumont Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.