Reverse Shoulder Prosthesis Study - Full Text View

Sponsor:	Encore Medical, L.P.
Information provided by:	Encore Medical, L.P.
ClinicalTrials.gov Identifier:	NCT00764504

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 III

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:

MedlinePlus related topics: Joint Disorders

U.S. FDA Resources

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

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:

Sponsor company home page This link exits the ClinicalTrials.gov site

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 February 12, 2012