Reverse Shoulder Prosthesis Study

Rotator Cuff Arthropathy Clinical Trial

— RSP  

Official title:

Encore Reverse Shoulder Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764504
• Other study ID #: Study 300
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: March 21, 2011
• Start date: October 2002
• Est. completion date: August 2008

Study information

• Verified date: March 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
• Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

Locations

Country	Name	City	State
United States	Crystal Clinic	Akron	Ohio
United States	Atlantis Orthopaedics	Atlantis	Florida
United States	TRIA Orthopaedic Center	Bloomington	Minnesota
United States	UNC School of Medicine	Chapel Hill	North Carolina
United States	Cincinnati Sports Medicine & Orthopaedic Center	Crestview	Kentucky
United States	Orthopedic Associates of Dallas	Dallas	Texas
United States	The Carrell Clinic	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Orthopedic Center of the Rockies	Ft. Collins	Colorado
United States	Orthopedic Specialty Associates, P.A.	Ft. Worth	Texas
United States	Arthritis Orthopedics and Sports Medicine	Glendale	California
United States	Orthopaedic Surgery & Sports Medicine	Jupiter	Florida
United States	Advanced Orthopedic and Sports Medicine Specialists, P.C.	Lonetree	Colorado
United States	Hospital for Special Surgery	New York	New York
United States	Bone & Joint Hospital, LLC	Oklahoma City	Oklahoma
United States	Orthopaedic Specialty Institute	Orange	California
United States	Palm Beach Orthopaedic Institute	Palm Beach Gardens	Florida
United States	Unlimited Research	San Antonio	Texas
United States	Orthopedic Research Foundation of the Carolinas	Spartanburg	South Carolina
United States	Florida Orthopedic Institute	Temple Terrace	Florida
United States	Orthopedic Specialists	Towson	Maryland
United States	Orthopedic Institute	Tyler	Texas
United States	Steadman Hawkins SPT Medical Foundation	Vail	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	2-year	No
Primary	Average Range of Motion	Physician's assessment of a subject's range of motion in degrees.	2-year	No
Primary	Subject Satisfaction With Surgery	Each subject had a chance to rate their satisfaction with surgery at each study interval.	2-year	No
Primary	Have Surgery Again?	Subject satisfaction: subject's willingness to have surgery performed again if necessary.	2-year	No
Primary	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.	2-year	No
Primary	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.	Post-operative, 3-month, 6-month, 1-year, 2-year	Yes
Primary	Safety Assessment	Number of device related adverse events and device failures at the 2 year time frame.	2-year	Yes

External Links

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