CompletedNot Applicable

COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

South Korea100 participantsStarted 2013-12

Plain-language summary

Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

Age range60 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
✓. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
✓. Grossly deficient rotator cuff with severe arthropathy and/or
✓. Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
✓. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
✓. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
✓. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

✕. 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.

Survivorship

Timeframe: 1 year

NCT IDNCT02084693

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-04