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Reverse Shoulder Prosthesis Study (RSP)

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: NCT00764504
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Encore Medical, L.P.

September 30, 2008
October 2, 2008
November 19, 2010
April 19, 2011
April 19, 2011
October 2002
June 2008   (Final data collection date for primary outcome measure)
  • American Shoulder and Elbow Surgeons Shoulder Score [ Time Frame: 2-year ]

    The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:

    [(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]

  • Average Range of Motion [ Time Frame: 2-year ]
    Physician's assessment of a subject's range of motion in degrees.
  • Subject Satisfaction With Surgery [ Time Frame: 2-year ]
    Each subject had a chance to rate their satisfaction with surgery at each study interval.
  • Have Surgery Again? [ Time Frame: 2-year ]
    Subject satisfaction: subject's willingness to have surgery performed again if necessary.
  • Neer's "Limited Goals" [ Time Frame: 2-year ]
    To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.
  • Radiographic Failures [ Time Frame: Post-operative, 3-month, 6-month, 1-year, 2-year ]
    Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.
  • Safety Assessment [ Time Frame: 2-year ]
    Number of device related adverse events and device failures at the 2 year time frame.
The RSP will perform as well as the literature controls at the 2 year evaluation. [ Time Frame: 2-year ]
Complete list of historical versions of study NCT00764504 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Rotator Cuff Arthropathy
  • Failed Total Shoulder
  • Failed Hemi-arthroplasty
  • Device: Reverse Shoulder Prosthesis
    For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
  • Device: Reverse Shoulder Prosthesis
    For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
  • Experimental: Primary
    Primary shoulder
    Intervention: Device: Reverse Shoulder Prosthesis
  • Experimental: Revision
    Revision shoulder
    Intervention: Device: Reverse Shoulder Prosthesis
  • Experimental: Continued Access
    Primary shoulder subjects enrolled at a later date in order to collect more data.
    Intervention: Device: Reverse Shoulder Prosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00764504
Study 300
No
Not Provided
Not Provided
Jane M. Jacob Ph.D., DJO Surgical
Encore Medical, L.P.
Not Provided
Principal Investigator: Mark Frankle, M.D. Florida Orthopedic Institute
Encore Medical, L.P.
March 2011

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