CompletedPhase 3

Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

United States157 participantsStarted 2011-07

Plain-language summary

The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.

Age range22 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.

✕. Rapid joint destruction, marked bone loss or bone resorption;
✕. Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
✕. Osteomalacia
✕. Glenohumeral joint infection
✕. Osteomyelitis

Device Success Rate

Timeframe: 24 months

NCT IDNCT01390038

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2016-02-16