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Reverse Shoulder Prosthesis Study (RSP)

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ClinicalTrials.gov Identifier: NCT00764504
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Encore Medical, L.P.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rotator Cuff Arthropathy
Failed Total Shoulder
Failed Hemi-arthroplasty
Intervention Device: Reverse Shoulder Prosthesis
Enrollment 516
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device. Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Period Title: Overall Study
Started 141 141 234
Completed 75 71 131
Not Completed 66 70 103
Reason Not Completed
Death             12             6             13
Revision of Device             12             23             14
Physician Decision             1             0             0
Withdrawal by Subject             1             7             4
Lost to Follow-up             40             34             72
Arm/Group Title Primary Revision Continued Access Total
Hide Arm/Group Description Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device. Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder. Total of all reporting groups
Overall Number of Baseline Participants 141 141 234 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 141 participants 234 participants 516 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  21.3%
52
  36.9%
57
  24.4%
139
  26.9%
>=65 years
111
  78.7%
89
  63.1%
177
  75.6%
377
  73.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 141 participants 234 participants 516 participants
71.9  (9.5) 67.4  (11.6) 71.2  (9.2) 70.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 141 participants 234 participants 516 participants
Female
87
  61.7%
97
  68.8%
136
  58.1%
320
  62.0%
Male
54
  38.3%
44
  31.2%
98
  41.9%
196
  38.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 141 participants 141 participants 234 participants 516 participants
141 141 234 516
Operative Shoulder  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants 141 participants 234 participants 516 participants
Right 87 83 146 316
Left 54 58 88 200
1.Primary Outcome
Title American Shoulder and Elbow Surgeons Shoulder Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 59 49 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
76  (18.5) 62  (18.5) 77  (18.1)
2.Primary Outcome
Title Average Range of Motion
Hide Description Physician's assessment of a subject's range of motion in degrees.
Time Frame 2-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 59 49 98
Mean (Standard Deviation)
Unit of Measure: Angle of Degrees of Shoulder Motion
Active forward elevation 119.6  (39.3) 84.4  (36.5) 120.4  (34.7)
Active external rotation 33.3  (19.0) 23.3  (18.7) 37.1  (24.2)
Active cross body adduction 25.8  (18.6) 13.9  (15.6) 27.4  (20.6)
3.Primary Outcome
Title Subject Satisfaction With Surgery
Hide Description Each subject had a chance to rate their satisfaction with surgery at each study interval.
Time Frame 2-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 59 49 98
Measure Type: Number
Unit of Measure: participants
Excellent 31 20 60
Good 18 12 27
Satisfactory 6 13 9
Unsatisfactory 4 4 2
4.Primary Outcome
Title Have Surgery Again?
Hide Description Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Time Frame 2-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 59 49 98
Measure Type: Number
Unit of Measure: participants
Yes 52 40 88
No 7 9 10
5.Primary Outcome
Title Neer's "Limited Goals"
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 59 49 98
Measure Type: Number
Unit of Measure: participants
Yes - criteria met 33 9 59
No - criteria not met 26 40 39
6.Primary Outcome
Title Radiographic Failures
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 69 62 127
Measure Type: Number
Unit of Measure: participants
0 0 0
7.Primary Outcome
Title Safety Assessment
Hide Description Number of device related adverse events and device failures at the 2 year time frame.
Time Frame 2-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description:
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
Overall Number of Participants Analyzed 156 162 249
Measure Type: Number
Unit of Measure: adverse events
Revisions of device 12 23 14
Number of device related adverse events 27 25 14
Total number of operative site adverse events 87 117 91
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary Revision Continued Access
Hide Arm/Group Description Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device. Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
All-Cause Mortality
Primary Revision Continued Access
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primary Revision Continued Access
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/156 (0.00%)      0/162 (0.00%)      0/249 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Primary Revision Continued Access
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   116/156 (74.36%)      113/162 (69.75%)      157/249 (63.05%)    
Blood and lymphatic system disorders       
Anemia / Bleeding   1/156 (0.64%)  1 8/162 (4.94%)  9 0/249 (0.00%)  0
Edema   5/156 (3.21%)  5 7/162 (4.32%)  8 4/249 (1.61%)  4
Cardiac disorders       
Heart Complications   10/156 (6.41%)  11 3/162 (1.85%)  5 11/249 (4.42%)  11
Immune system disorders       
Cancer   5/156 (3.21%)  5 3/162 (1.85%)  3 5/249 (2.01%)  5
Infections and infestations       
Infections   4/156 (2.56%)  4 13/162 (8.02%)  18 16/249 (6.43%)  17
Musculoskeletal and connective tissue disorders       
Dislocation   9/156 (5.77%)  14 21/162 (12.96%)  25 9/249 (3.61%)  13
Fracture   16/156 (10.26%)  16 16/162 (9.88%)  16 21/249 (8.43%)  23
Musculoskeletal Pain   57/156 (36.54%)  81 47/162 (29.01%)  64 68/249 (27.31%)  103
Nervous system disorders       
Neurological disorder and numbness   4/156 (2.56%)  4 5/162 (3.09%)  5 8/249 (3.21%)  8
Respiratory, thoracic and mediastinal disorders       
Pneumonia *  1/156 (0.64%)  1 3/162 (1.85%)  3 7/249 (2.81%)  7
Social circumstances       
Death - Natural Causes   9/156 (5.77%)  9 5/162 (3.09%)  5 13/249 (5.22%)  13
Surgical and medical procedures       
Broken Device / Component   4/156 (2.56%)  4 2/162 (1.23%)  2 0/249 (0.00%)  0
Broken Screw  [1]  9/156 (5.77%)  11 3/162 (1.85%)  3 2/249 (0.80%)  2
Device Instability / Failure  [2]  11/156 (7.05%)  11 16/162 (9.88%)  17 8/249 (3.21%)  8
Vascular disorders       
Stroke   2/156 (1.28%)  2 1/162 (0.62%)  1 4/249 (1.61%)  6
Swelling   3/156 (1.92%)  3 3/162 (1.85%)  3 6/249 (2.41%)  6
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
screws are used to secure parts of the device to bone and will occasionally break.
[2]
Device became unstable or failed which required a revision surgery.
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
Name/Title: Manager of Clinical Affairs
Organization: DJO Surgical
Phone: 512-832-9500 ext 6323
Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764504     History of Changes
Other Study ID Numbers: Study 300
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: November 19, 2010
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011