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

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.


Condition Intervention Phase
Rotator Cuff Arthropathy
Failed Total Shoulder
Failed Hemi-Arthroplasty
Device: Reverse Shoulder Prosthesis
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Encore Reverse Shoulder Prosthesis

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • The RSP will perform as well as the literature controls at the 2 year evaluation. [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Enrollment: 569
Study Start Date: October 2002
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary: Experimental
Primary shoulder
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Revision: Experimental
Revision shoulder
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764504

  Show 25 Study Locations
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: Mark Frankle, M.D. Florida Orthopedic Institute
  More Information

Additional Information:
No publications provided

Responsible Party: DJO Surgical ( Jane M. Jacob Ph.D. )
Study ID Numbers: Study 300
Study First Received: September 30, 2008
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00764504     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Musculoskeletal Diseases
Joint Diseases

ClinicalTrials.gov processed this record on November 27, 2009