NCT03404778
Comprehensive Reverse Shoulder Data Collection
Enrolling by Invitation
Not specifiedAges 18+ObservationalZimmer Biomet
~175 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Biomet Comprehensive Reverse Shoulder
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Score
Measured over 1 year
Conditions
Where it's being run
4 sites across 4 statesMaryland1
Michigan1
Minnesota1
Ohio1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Pain Score1 year
Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.