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Retrospective Encore Reverse Shoulder Prosthesis Study

This study has been completed.
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00765037
First received: September 30, 2008
Last updated: August 3, 2010
Last verified: August 2010
  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 4

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

ClinicalTrials.gov processed this record on November 20, 2014