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NCT01878253 · ClinicalTrials.gov registry record · NA

Sidus Stem-Free Shoulder IDE Study

A NA study, sponsored by Zimmer Biomet.

Completed
Registry status
NA
Development phase
95
Enrollment target

NCT01878253: Completed NA study, sponsored by Zimmer Biomet.

NCT01878253 is a NA study that has completed, run by Zimmer Biomet. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01878253, a NA study, has completed, sponsored by Zimmer Biomet.

COMPLETED
Registry status
NA
Development phase
95 participants
Enrollment target

Study Summary

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Primary Outcome

Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3.

Interventions

  • DEVICE Sidus Stem-Free Total Shoulder Arthroplasty System

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2013-07
Est. Completion 2019-01
Phase NA
Zimmer Biomet

115 total trials

What the finished NCT01878253 record still lists

NCT01878253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Sidus Stem-Free Total Shoulder Arthroplasty System is the first listed.

NCT01878253 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01878253 about?

NCT01878253 is a clinical study titled "Sidus Stem-Free Shoulder IDE Study". The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

What is the current status of trial NCT01878253?

This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2013-07. Estimated completion is 2019-01.

What interventions are being tested in trial NCT01878253?

The interventions under investigation include: Sidus Stem-Free Total Shoulder Arthroplasty System (DEVICE).

Who is sponsoring clinical trial NCT01878253?

This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01878253's enrollment target sits among peer trials

95 931st of 2000 higher than 1,066 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01878253, the US trial registry maintained by the National Library of Medicine. NCT01878253 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.