Reverse Shoulder Prosthesis Study (RSP)

This study has been completed.
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764504
First received: September 30, 2008
Last updated: March 21, 2011
Last verified: March 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Encore Reverse Shoulder Prosthesis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • American Shoulder and Elbow Surgeons Shoulder Score [ Time Frame: 2-year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Physician's assessment of a subject's range of motion in degrees.

  • Subject Satisfaction With Surgery [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    Each subject had a chance to rate their satisfaction with surgery at each study interval.

  • Have Surgery Again? [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    Subject satisfaction: subject's willingness to have surgery performed again if necessary.

  • Neer's "Limited Goals" [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of device related adverse events and device failures at the 2 year time frame.


Enrollment: 516
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
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.

  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
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, see Learn About Clinical Studies.

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: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764504     History of Changes
Other Study ID Numbers: Study 300
Study First Received: September 30, 2008
Results First Received: November 19, 2010
Last Updated: March 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014