Retrospective Encore Reverse Shoulder Prosthesis Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 30, 2008

Last Updated Date

October 9, 2008

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The survivorship and efficacy of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00765037 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Retrospective Encore Reverse Shoulder Prosthesis Study

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Rotator Cuff Deficiency
Glenohumeral Arthritis

Intervention ^ICMJE

Device: Encore Reverse Shoulder Prosthesis

Study Arms / Comparison Groups

Other: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00765037

Responsible Party

Jane M. Jacob Ph.D., DJO Surgical

Study ID Numbers ^ICMJE

PS - 902

Study Sponsor ^ICMJE

Encore Medical, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

J. Michael Kioschos, M.D.

Nashville Orthopedic Specialists

Information Provided By

Encore Medical, L.P.

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP