Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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 ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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