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Reverse Shoulder Prosthesis Study (RSP)
This study has been completed.
Study NCT00764504   Information provided by Encore Medical, L.P.
First Received: September 30, 2008   Last Updated: October 9, 2008   History of Changes

September 30, 2008
October 9, 2008
October 2002
June 2008   (final data collection date for primary outcome measure)
The RSP will perform as well as the literature controls at the 2 year evaluation. [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00764504 on ClinicalTrials.gov Archive Site
 
 
 
Reverse Shoulder Prosthesis Study
Encore Reverse Shoulder Prosthesis

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
  • Rotator Cuff Arthropathy
  • Failed Total Shoulder
  • Failed Hemi-Arthroplasty
Device: Reverse Shoulder Prosthesis
  • Experimental: Primary shoulder
  • Experimental: Revision shoulder
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
569
August 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
  • Evidence of upward displacement of the humeral head with respect to the glenoid
  • Loss of glenohumeral joint space
  • Functional deltoid muscle
  • Patient is likely to be available for evaluation for the duration of the study
  • Visual Analog Pain Scale 5 or greater

Exclusion Criteria:

  • Non functional deltoid muscle
  • Active sepsis
  • Excessive glenoid bone loss
  • Pregnancy
  • Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
  • Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
  • Prisoners
  • Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
  • Known metal allergy (i.e., jewelry).
  • Visual Analog Pain Scale <5.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764504
Jane M. Jacob Ph.D., DJO Surgical
Study 300
Encore Medical, L.P.
 
Principal Investigator: Mark Frankle, M.D. Florida Orthopedic Institute
Encore Medical, L.P.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP