Retrospective Encore Reverse Shoulder Prosthesis Study

This study has been completed.

First Received on September 30, 2008. Last Updated on August 3, 2010 History of Changes

Sponsor:	Encore Medical, L.P.
Information provided by:	Encore Medical, L.P.
ClinicalTrials.gov Identifier:	NCT00765037

Purpose

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.

Condition	Intervention	Phase
Rotator Cuff Deficiency Glenohumeral Arthritis	Device: Encore Reverse Shoulder Prosthesis	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects

Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:

Survivorship of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of subjects who completed all study visits through the 1 year visit.

Enrollment:	19
Study Start Date:	August 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765037

Locations

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

Sponsors and Collaborators

Encore Medical, L.P.

Investigators

Principal Investigator:

J. Michael Kioschos, M.D.

Nashville Orthopedic Specialists

More Information

Additional Information:

Sponsor Company home page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier:	NCT00765037 History of Changes
Other Study ID Numbers:	PS - 902
Study First Received:	September 30, 2008
Results First Received:	June 8, 2009
Last Updated:	August 3, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 13, 2012