Retrospective Encore Reverse Shoulder Prosthesis Study
Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
1 other identifier
observational
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 25, 2010
CompletedAugust 25, 2010
August 1, 2010
9 months
September 30, 2008
June 8, 2009
August 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Survivorship of the Encore Reverse Shoulder Prosthesis
Number of subjects who completed all study visits through the 1 year visit.
1 year
Study Arms (1)
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.
Interventions
rotator cuff deficiency and glenohumeral arthritis
Eligibility Criteria
Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nashville Orthopedic Specialists
Nashville, Tennessee, 37203, United States
Related Links
Results Point of Contact
- Title
- Jane M. Jacob - Manager of Clinical Affairs
- Organization
- DJO Surgical
Study Officials
- PRINCIPAL INVESTIGATOR
J. Michael Kioschos, M.D.
Nashville Orthopedic Specialists
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
August 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 25, 2010
Results First Posted
August 25, 2010
Record last verified: 2010-08