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Retrospective Encore Reverse Shoulder Prosthesis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

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 Phase
Rotator Cuff Deficiency Glenohumeral Arthritis Device: Encore Reverse Shoulder Prosthesis Phase 4

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
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
U.S. FDA Resources

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



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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

Additional Information:
Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00765037     History of Changes
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