CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 516 enrolled
Drug / intervention
Reverse Shoulder Prosthesis +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00764504
NCT00764504Phase 3Completed
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Encore Reverse Shoulder Prosthesis

Encore Medical, L.P.·interventional·Posted Oct 2, 2008·Updated Apr 19, 2011

In Brief

A Phase 3 clinical trial evaluating Reverse Shoulder Prosthesis for Rotator Cuff Arthropathy and 2 related conditions. Completed, enrolled 516 participants across 25 sites.

Detailed Summary

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2008
Enrollment StartOct 1, 2002
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 17.8 years ago

Interventions

Reverse Shoulder Prosthesisdevice

For subjects with rotator cuff arthropathy and no previous shoulder device implanted.

Reverse Shoulder Prosthesisdevice

For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.