What this study is
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.
What's being tested
- Biomet Comprehensive Reverse Shoulder
Intervention · DEVICE
Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.
Study details
- Official title
- Comprehensive Reverse Shoulder Clinical Outcomes Study
- 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
- Enrolling
- 175 people
- Starts
- 2010-03-07
- Est. completion
- 2036-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openAcromion 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
Study team
Sponsor
Zimmer Biomet
Study ID ORTHO.CR.EX007
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.