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Retrospective Encore Reverse Shoulder Prosthesis Study

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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:
Information provided by:
Encore Medical, L.P.

Study Description
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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.

Condition or disease Intervention/treatment
Rotator Cuff Deficiency Glenohumeral Arthritis Device: Encore Reverse Shoulder Prosthesis

Study Design
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Study Type : Observational
Actual Enrollment : 19 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Survivorship of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ]
    Number of subjects who completed all study visits through the 1 year visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765037


Locations
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United States, Tennessee
Nashville Orthopedic Specialists
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
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Principal Investigator: J. Michael Kioschos, M.D. Nashville Orthopedic Specialists
More Information
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Additional Information:

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Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00765037    
Other Study ID Numbers: PS - 902
First Posted: October 2, 2008    Key Record Dates
Results First Posted: August 25, 2010
Last Update Posted: August 25, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases