Retrospective Encore Reverse Shoulder Prosthesis Study

• ClinicalTrials.gov Identifier: NCT00765037
• Recruitment Status: Completed
• First Posted: October 2, 2008
• Results First Posted: August 25, 2010
• Last Update Posted: August 25, 2010
• Sponsor: Encore Medical, L.P.
• Information provided by: Encore Medical, L.P.

Tracking Information

• First Submitted Date: September 30, 2008
• First Posted Date: October 2, 2008
• Results First Submitted Date: June 8, 2009
• Results First Posted Date: August 25, 2010
• Last Update Posted Date: August 25, 2010
• Study Start Date: August 2008
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2010)

Survivorship of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ]

Number of subjects who completed all study visits through the 1 year visit.

• Original Primary Outcome Measures (submitted: October 1, 2008): The survivorship and efficacy of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Retrospective Encore Reverse Shoulder Prosthesis Study
• Official Title: 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: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

• Rotator Cuff Deficiency
• Glenohumeral Arthritis

Intervention

Device: Encore Reverse Shoulder Prosthesis

rotator cuff deficiency and glenohumeral arthritis

Study Groups/Cohorts

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.

Intervention: Device: Encore Reverse Shoulder Prosthesis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 3, 2010): 19
• Original Estimated Enrollment (submitted: October 1, 2008): 50
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00765037
• Other Study ID Numbers: PS - 902
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
• Study Sponsor: Encore Medical, L.P.
• Collaborators: Not Provided

Investigators

• Principal Investigator: J. Michael Kioschos, M.D.; Nashville Orthopedic Specialists

• PRS Account: Encore Medical, L.P.
• Verification Date: August 2010