Retrospective Encore Reverse Shoulder Prosthesis Study
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ClinicalTrials.gov Identifier: NCT00765037 |
Recruitment Status :
Completed
First Posted : October 2, 2008
Results First Posted : August 25, 2010
Last Update Posted : August 25, 2010
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Sponsor:
Encore Medical, L.P.
Information provided by:
Encore Medical, L.P.
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Study Type | Observational |
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Study Design | Observational Model: Cohort; Time Perspective: Retrospective |
Conditions |
Rotator Cuff Deficiency Glenohumeral Arthritis |
Intervention |
Device: Encore Reverse Shoulder Prosthesis |
Enrollment | 19 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Encore RSP |
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Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. |
Period Title: Overall Study | |
Started | 19 [1] |
Completed | 13 [2] |
Not Completed | 6 |
Reason Not Completed | |
Lost to Follow-up | 5 |
Adverse Event | 1 |
[1]
Original number of eligible subjects who signed a consent form.
[2]
Subjects who came in for 1 year visit.
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Baseline Characteristics
Arm/Group Title | Encore RSP | |
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Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. | |
Overall Number of Baseline Participants | 19 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
19 100.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 19 participants | |
75 (4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
Female |
14 73.7%
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Male |
5 26.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 19 participants |
19 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jane M. Jacob - Manager of Clinical Affairs |
Organization: | DJO Surgical |
Phone: | 512-834-6323 |
EMail: | jane.jacob@djosurgical.com |
Responsible Party: | Jane M. Jacob Ph.D., DJO Surgical |
ClinicalTrials.gov Identifier: | NCT00765037 |
Other Study ID Numbers: |
PS - 902 |
First Submitted: | September 30, 2008 |
First Posted: | October 2, 2008 |
Results First Submitted: | June 8, 2009 |
Results First Posted: | August 25, 2010 |
Last Update Posted: | August 25, 2010 |