Retrospective Encore Reverse Shoulder Prosthesis Study

This study has been completed.

Study NCT00765037 Information provided by Encore Medical, L.P.

First Received on September 30, 2008. Last Updated on August 3, 2010 History of Changes

Results First Received: June 8, 2009

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Conditions:	Rotator Cuff Deficiency Glenohumeral Arthritis
Intervention:	Device: Encore Reverse Shoulder Prosthesis

Participant Flow

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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
Encore RSP	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.

Participant Flow: Overall Study

	Encore RSP
STARTED	19 ^[1]
COMPLETED	13 ^[2]
NOT COMPLETED	6
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.

Baseline Characteristics

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Reporting Groups

	Description
Encore RSP	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.

Baseline Measures

	Encore RSP
Number of Participants [units: participants]	19
Age [units: participants]
<=18 years	0
Between 18 and 65 years	0
>=65 years	19
Age [units: years] Mean ± Standard Deviation	75 ± 4
Gender [units: participants]
Female	14
Male	5
Region of Enrollment [units: participants]
United States	19

Outcome Measures

1. Primary:

Survivorship of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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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Results Point of Contact:

Name/Title: Jane M. Jacob - Manager of Clinical Affairs
Organization: DJO Surgical
phone: 512-834-6323
e-mail: jane.jacob@djosurgical.com

No publications provided

Responsible Party:	Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier:	NCT00765037 History of Changes
Other Study ID Numbers:	PS - 902
Study First Received:	September 30, 2008
Results First Received:	June 8, 2009
Last Updated:	August 3, 2010
Health Authority:	United States: Institutional Review Board