Comprehensive Reverse Shoulder Data Collection
Enrolling by invitation
Conditions studied: Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthitis
In brief
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.
Key facts
- Study ID
- NCT03404778
- Run by
- Zimmer Biomet
- People needed
- 175
- Starts
- 2010-03-07
- Expected to finish
- 2036-12-01
- Last updated by the study team
- 2025-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Acromion LLC — Towson, Maryland, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- Allina Health System DBA Sports and Orthopaedic Specialists — Edina, Minnesota, United States
- Joint Implant Surgeons — New Albany, Ohio, United States
Full record on ClinicalTrials.gov
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