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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Primary Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Revision 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.
Continued Access 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.

Participant Flow:   Overall Study
    Primary   Revision   Continued Access
STARTED   141   141   234 
COMPLETED   75   71   131 
NOT COMPLETED   66   70   103 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Primary Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Revision 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.
Continued Access 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 Total of all reporting groups

Baseline Measures
   Primary   Revision   Continued Access   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   141   234   516 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   30   52   57   139 
>=65 years   111   89   177   377 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.9  (9.5)   67.4  (11.6)   71.2  (9.2)   70.4  (10.1) 
Gender 
[Units: Participants]
       
Female   87   97   136   320 
Male   54   44   98   196 
Region of Enrollment 
[Units: Participants]
       
United States   141   141   234   516 
Operative Shoulder 
[Units: Participants]
       
Right   87   83   146   316 
Left   54   58   88   200 


  Outcome Measures

1.  Primary:   American Shoulder and Elbow Surgeons Shoulder Score   [ Time Frame: 2-year ]

2.  Primary:   Average Range of Motion   [ Time Frame: 2-year ]

3.  Primary:   Subject Satisfaction With Surgery   [ Time Frame: 2-year ]

4.  Primary:   Have Surgery Again?   [ Time Frame: 2-year ]

5.  Primary:   Neer's "Limited Goals"   [ Time Frame: 2-year ]

6.  Primary:   Radiographic Failures   [ Time Frame: Post-operative, 3-month, 6-month, 1-year, 2-year ]

7.  Primary:   Safety Assessment   [ Time Frame: 2-year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: jane.jacob@djosurgical.com



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