Reverse Shoulder Prosthesis Study (RSP)

March 21, 2011 updated by: Encore Medical, L.P.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

516

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Arthritis Orthopedics and Sports Medicine
      • Orange, California, United States, 92868
        • Orthopaedic Specialty Institute
    • Colorado
      • Denver, Colorado, United States, 80054
        • University of Colorado
      • Ft. Collins, Colorado, United States, 80525
        • Orthopedic Center of the Rockies
      • Lonetree, Colorado, United States, 80124
        • Advanced Orthopedic and Sports Medicine Specialists, P.C.
      • Vail, Colorado, United States, 81657
        • Steadman Hawkins SPT Medical Foundation
    • Florida
      • Atlantis, Florida, United States, 33462
        • Atlantis Orthopaedics
      • Jupiter, Florida, United States, 33458
        • Orthopaedic Surgery & Sports Medicine
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Orthopaedic Institute
      • Temple Terrace, Florida, United States, 33637
        • Florida Orthopedic Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Kentucky
      • Crestview, Kentucky, United States, 41017
        • Cincinnati Sports Medicine & Orthopaedic Center
    • Maryland
      • Lutherville, Maryland, United States, 21093
      • Towson, Maryland, United States, 21204
        • Orthopedic Specialists
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • TRIA Orthopaedic Center
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC School of Medicine
    • Ohio
      • Akron, Ohio, United States, 44333
        • Crystal Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Bone & Joint Hospital, LLC
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Orthopedic Research Foundation of the Carolinas
    • Texas
      • Dallas, Texas, United States, 75231
        • The Carrell Clinic
      • Dallas, Texas, United States, 75246
        • Orthopedic Associates of Dallas
      • Ft. Worth, Texas, United States, 76104
        • Orthopedic Specialty Associates, P.A.
      • San Antonio, Texas, United States, 78217
        • Unlimited Research
      • Tyler, Texas, United States, 75701
        • Orthopedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary
Primary shoulder
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: Revision
Revision shoulder
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: 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.
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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-year
Average Range of Motion
Time Frame: 2-year
Physician's assessment of a subject's range of motion in degrees.
2-year
Subject Satisfaction With Surgery
Time Frame: 2-year
Each subject had a chance to rate their satisfaction with surgery at each study interval.
2-year
Have Surgery Again?
Time Frame: 2-year
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
2-year
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.
2-year
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.
Post-operative, 3-month, 6-month, 1-year, 2-year
Safety Assessment
Time Frame: 2-year
Number of device related adverse events and device failures at the 2 year time frame.
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encore Medical, L.P.

Investigators

  • Principal Investigator: Mark Frankle, M.D., Florida Orthopedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

March 21, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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