Comprehensive Reverse Shoulder Data Collection (NCT03404778) | Clinical Trial Compass
By InvitationNot Applicable
Comprehensive Reverse Shoulder Data Collection
United States175 participantsStarted 2010-03-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* BiometĀ® Comprehensiveā¢ 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 ComprehensiveĀ® 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.