NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingNA

Sponsor: Zimmer Biomet

Conditions: Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthritis

Interventions: Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (6)

Gulf Breeze, Florida, United States
Louisville, Kentucky, United States
Royal Oak, Michigan, United States
Buffalo, New York, United States
Germantown, Tennessee, United States
Charlottesville, Virginia, United States