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Comprehensive Reverse Shoulder Data Collection
Comprehensive Reverse Shoulder Data Collection

NCT03404778

Enrolling By InvitationN/A

Sponsor: Zimmer Biomet

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

Interventions: Biomet Comprehensive Reverse Shoulder

Countries: United States

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
* The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
* The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria:

* Absolute contraindications include infection, sepsis, and osteomyelitis.
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Osteoporosis.
* Metabolic disorders which may impair bone formation.
* Osteomalacia.
* Distant foci of infections which may spread to the implant site.
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Locations (4)
  • Towson, Maryland, United States
  • Royal Oak, Michigan, United States
  • Edina, Minnesota, United States
  • New Albany, Ohio, United States