NCT00764504

Reverse Shoulder Prosthesis Study

Encore Reverse Shoulder Prosthesis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Arthropathy
• Failed Total Shoulder
• Failed Hemi-arthroplasty

Interventions

Type	Name	Description
DEVICE	Reverse Shoulder Prosthesis	For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
DEVICE	Reverse Shoulder Prosthesis	For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

Timeline

• Start date: 2002-10-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2008-10-02
• Last updated: 2011-04-19
• Results posted: 2011-04-19

Locations

25 sites across 1 country: United States