Retrospective Encore Reverse Shoulder Prosthesis Study

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

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.

Study Overview

• Status: Completed
• Conditions: Glenohumeral Arthritis; Rotator Cuff Deficiency
• Intervention / Treatment: Device: Encore Reverse Shoulder Prosthesis

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Orthopedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Encore RSP; Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.	Device: Encore Reverse Shoulder Prosthesis; rotator cuff deficiency and glenohumeral arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of the Encore Reverse Shoulder Prosthesis	Number of subjects who completed all study visits through the 1 year visit.	1 year

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Investigators: Principal Investigator: J. Michael Kioschos, M.D., Nashville Orthopedic Specialists

Publications and helpful links

Helpful Links

• Sponsor company home page

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: PS - 902