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Reverse Shoulder Prosthesis Study (RSP)

Primary Purpose

Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reverse Shoulder Prosthesis
Reverse Shoulder Prosthesis
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arthritis Orthopedics and Sports Medicine
  • Orthopaedic Specialty Institute
  • University of Colorado
  • Orthopedic Center of the Rockies
  • Advanced Orthopedic and Sports Medicine Specialists, P.C.
  • Steadman Hawkins SPT Medical Foundation
  • Atlantis Orthopaedics
  • Orthopaedic Surgery & Sports Medicine
  • Palm Beach Orthopaedic Institute
  • Florida Orthopedic Institute
  • Cincinnati Sports Medicine & Orthopaedic Center
  • Orthopedic Specialists
  • TRIA Orthopaedic Center
  • Hospital for Special Surgery
  • UNC School of Medicine
  • Crystal Clinic
  • Bone & Joint Hospital, LLC
  • Orthopedic Research Foundation of the Carolinas
  • The Carrell Clinic
  • Orthopedic Associates of Dallas
  • Orthopedic Specialty Associates, P.A.
  • Unlimited Research
  • Orthopedic Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Primary

Revision

Continued Access

Arm Description

Primary shoulder

Revision shoulder

Primary shoulder subjects enrolled at a later date in order to collect more data.

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeons Shoulder Score
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
Physician's assessment of a subject's range of motion in degrees.
Subject Satisfaction With Surgery
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Have Surgery Again?
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Neer's "Limited Goals"
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
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
Number of device related adverse events and device failures at the 2 year time frame.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
March 21, 2011
Sponsor
Encore Medical, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00764504
Brief Title
Reverse Shoulder Prosthesis Study
Acronym
RSP
Official Title
Encore Reverse Shoulder Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Encore Medical, L.P.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary
Arm Type
Experimental
Arm Description
Primary shoulder
Arm Title
Revision
Arm Type
Experimental
Arm Description
Revision shoulder
Arm Title
Continued Access
Arm Type
Experimental
Arm Description
Primary shoulder subjects enrolled at a later date in order to collect more data.
Intervention Type
Device
Intervention Name(s)
Reverse Shoulder Prosthesis
Intervention Description
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Intervention Type
Device
Intervention Name(s)
Reverse Shoulder Prosthesis
Intervention Description
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Shoulder Score
Description
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]
Time Frame
2-year
Title
Average Range of Motion
Description
Physician's assessment of a subject's range of motion in degrees.
Time Frame
2-year
Title
Subject Satisfaction With Surgery
Description
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Time Frame
2-year
Title
Have Surgery Again?
Description
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Time Frame
2-year
Title
Neer's "Limited Goals"
Description
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.
Time Frame
2-year
Title
Radiographic Failures
Description
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.
Time Frame
Post-operative, 3-month, 6-month, 1-year, 2-year
Title
Safety Assessment
Description
Number of device related adverse events and device failures at the 2 year time frame.
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Frankle, M.D.
Organizational Affiliation
Florida Orthopedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Orthopedics and Sports Medicine
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Orthopaedic Specialty Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80054
Country
United States
Facility Name
Orthopedic Center of the Rockies
City
Ft. Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Advanced Orthopedic and Sports Medicine Specialists, P.C.
City
Lonetree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Steadman Hawkins SPT Medical Foundation
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States
Facility Name
Atlantis Orthopaedics
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Orthopaedic Surgery & Sports Medicine
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Palm Beach Orthopaedic Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Florida Orthopedic Institute
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Cincinnati Sports Medicine & Orthopaedic Center
City
Crestview
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Orthopedic Specialists
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
TRIA Orthopaedic Center
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Crystal Clinic
City
Akron
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Facility Name
Bone & Joint Hospital, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Orthopedic Research Foundation of the Carolinas
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
The Carrell Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Orthopedic Associates of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Orthopedic Specialty Associates, P.A.
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Unlimited Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Orthopedic Institute
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.djosurgical.com
Description
Sponsor company home page

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Reverse Shoulder Prosthesis Study

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