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.

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
. Osteoporosis.
. Metabolic disorders which may impair bone formation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survivorship

Timeframe: 1 year

Trial details

NCT IDNCT02084693

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-04

View on ClinicalTrials.gov More Rotator Cuff Tear Arthropathy trials