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NCT01005446 · ClinicalTrials.gov registry record
Reverse Shoulder Prosthesis Prospective Multi-Center Study
A clinical trial, sponsored by Encore Medical, L.P..
- Completed
- Registry status
- 245
- Enrollment target
NCT01005446: Completed study, sponsored by Encore Medical, L.P..
NCT01005446 is a clinical trial that has completed, run by Encore Medical, L.P.. The registered enrollment target is 245 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005446 has completed, sponsored by Encore Medical, L.P..
- COMPLETED
- Registry status
- 245 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
Primary Outcome
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
Interventions
- DEVICE Encore Reverse Shoulder Prosthesis (RSP®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2009-12 |
| Est. Completion | 2018-06 |
What the finished NCT01005446 record still lists
NCT01005446 is an observational study that tracks outcomes without assigning an intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Encore Reverse Shoulder Prosthesis (RSP®) is the first listed.
NCT01005446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005446 about?
NCT01005446 is a clinical study titled "Reverse Shoulder Prosthesis Prospective Multi-Center Study". The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
What is the current status of trial NCT01005446?
This trial is currently completed. The enrollment target is 245 participants. The study started on 2009-12. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01005446?
The interventions under investigation include: Encore Reverse Shoulder Prosthesis (RSP®) (DEVICE).
Who is sponsoring clinical trial NCT01005446?
This trial is sponsored by Encore Medical, L.P., which has 16 total clinical trials registered on ClinicalTrials.gov.
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