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

Brief Summary:
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 or disease Intervention/treatment Phase
Rotator Cuff Arthropathy Failed Total Shoulder Failed Hemi-arthroplasty Device: Reverse Shoulder Prosthesis Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Encore Reverse Shoulder Prosthesis
Study Start Date : October 2002
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Primary
Primary shoulder
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.

Experimental: Revision
Revision shoulder
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

Experimental: Continued Access
Primary shoulder subjects enrolled at a later date in order to collect more data.
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.

Primary Outcome Measures :
  1. 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]

  2. Average Range of Motion [ Time Frame: 2-year ]
    Physician's assessment of a subject's range of motion in degrees.

  3. Subject Satisfaction With Surgery [ Time Frame: 2-year ]
    Each subject had a chance to rate their satisfaction with surgery at each study interval.

  4. Have Surgery Again? [ Time Frame: 2-year ]
    Subject satisfaction: subject's willingness to have surgery performed again if necessary.

  5. 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.

  6. 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.

  7. Safety Assessment [ Time Frame: 2-year ]
    Number of device related adverse events and device failures at the 2 year time frame.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764504

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Sponsors and Collaborators
Encore Medical, L.P.
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Principal Investigator: Mark Frankle, M.D. Florida Orthopedic Institute
Additional Information:
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Responsible Party: Jane M. Jacob Ph.D., DJO Surgical Identifier: NCT00764504    
Other Study ID Numbers: Study 300
First Posted: October 2, 2008    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases