NCT01005446

Reverse Shoulder Prosthesis Prospective Multi-Center Study

PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.

Conditions

• Rotator Cuff Deficiency
• Shoulder Arthropathy
• Failed Shoulder Replacement

Interventions

Type	Name	Description
DEVICE	Encore Reverse Shoulder Prosthesis (RSP®)	The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

Timeline

• Start date: 2009-12-01
• Primary completion: 2017-08-01
• Completion: 2018-06-01
• First posted: 2009-11-02
• Last updated: 2021-03-30

Locations

10 sites across 1 country: United States