TerminatedNot Applicable

Clinical Evaluation of the TITAN™ Total Shoulder System

Stopped: Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.

United States50 participantsStarted 2017-03-20

Plain-language summary

A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
✓. The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
✓. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion criteria

✕. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
✕. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.

What they're measuring

Implant survival at 2 years

Timeframe: 2 years

Trial details

NCT IDNCT03245320

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-22

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