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Retrospective Encore Reverse Shoulder Prosthesis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765037
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
Encore Medical, L.P.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Rotator Cuff Deficiency
Glenohumeral Arthritis
Intervention Device: Encore Reverse Shoulder Prosthesis
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Encore RSP
Hide Arm/Group Description 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.
Arm/Group Title Encore RSP
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
19
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
75  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
14
  73.7%
Male
5
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Survivorship of the Encore Reverse Shoulder Prosthesis
Hide Description Number of subjects who completed all study visits through the 1 year visit.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Encore RSP
Hide Arm/Group Description:
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 Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
13
Time Frame The first subject was treated in 2005 and the final subject came in for their final follow-up visit in 2008. The study ran for 3 years but adverse events were only collected on subjects from their day of surgery through their one year follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Encore RSP
Hide Arm/Group Description 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.
All-Cause Mortality
Encore RSP
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Encore RSP
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Encore RSP
Affected / at Risk (%) # Events
Total   11/19 (57.89%)    
Infections and infestations   
Staph infection at IV site  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
Multiple contusions  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Back and Bilateral knee pain  1/19 (5.26%)  1
Forearm and Jaw fracture  1/19 (5.26%)  1
Increased left shoulder pain  3/19 (15.79%)  3
Increased right knee pain  1/19 (5.26%)  1
Increased right shoulder pain  2/19 (10.53%)  2
Left knee pain  1/19 (5.26%)  1
Nasal fracture  1/19 (5.26%)  1
Right humeral fracture  2/19 (10.53%)  2
Right middle trigger finger pain  2/19 (10.53%)  2
Right shoulder instability  1/19 (5.26%)  1
left elbow and hand pain  1/19 (5.26%)  1
Nervous system disorders   
Parkinson's Disease  1/19 (5.26%)  1
Right radial nerve palsy  1/19 (5.26%)  1
Renal and urinary disorders   
Bronchitis and bladder infection  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Bilateral pulmonary emboli  1/19 (5.26%)  1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane M. Jacob - Manager of Clinical Affairs
Organization: DJO Surgical
Phone: 512-834-6323
EMail: jane.jacob@djosurgical.com
Layout table for additonal information
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