Retrospective Encore Reverse Shoulder Prosthesis Study

Glenohumeral Arthritis Clinical Trial

Official title:

Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765037
• Other study ID #: PS - 902
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: August 3, 2010
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2010
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

• The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion Criteria:

• Infection or sepsis

• Insufficient bone quality which may affect the stability of the implant, as determined by the physician

• Muscular, neurological, or vascular deficiencies, which compromise the affected extremity

• Alcoholism or other addictions

• Materials (metals, etc) sensitivity

• Loss of ligamentous structures

• High levels of physical activity

• Non-functional deltoid muscle

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glenohumeral Arthritis
• Rotator Cuff Deficiency

Intervention

Device:
• Encore Reverse Shoulder Prosthesis
rotator cuff deficiency and glenohumeral arthritis

Locations

Country	Name	City	State
United States	Nashville Orthopedic Specialists	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of the Encore Reverse Shoulder Prosthesis	Number of subjects who completed all study visits through the 1 year visit.	1 year	No

External Links

•   Sponsor Company home page