Retrospective Encore Reverse Shoulder Prosthesis Study

• Sponsor: Encore Medical, L.P. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00765037
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Deficiency; Glenohumeral Arthritis	Device: Encore Reverse Shoulder Prosthesis

Study Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Encore Reverse Shoulder Prosthesis; rotator cuff deficiency and glenohumeral arthritis

Outcome Measures

Primary Outcome Measures

1. Survivorship of the Encore Reverse Shoulder Prosthesis [1 year]

   Number of subjects who completed all study visits through the 1 year visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

• The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion Criteria:

• Infection or sepsis

• Insufficient bone quality which may affect the stability of the implant, as determined by the physician

• Muscular, neurological, or vascular deficiencies, which compromise the affected extremity

• Alcoholism or other addictions

• Materials (metals, etc) sensitivity

• Loss of ligamentous structures

• High levels of physical activity

• Non-functional deltoid muscle

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nashville Orthopedic Specialists	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Encore Medical, L.P.

Investigators

• Principal Investigator: J. Michael Kioschos, M.D., Nashville Orthopedic Specialists

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor Company home page

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00765037
• Other Study ID Numbers: PS - 902
• First Posted: Oct 2, 2008
• Last Update Posted: Aug 25, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Arthritis

Study Results

Participant Flow

Arm/Group Title	Encore RSP
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
COMPLETED	13
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Encore RSP
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 Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	19 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75 (4)
Sex: Female, Male (Count of Participants)
Female	14 73.7%
Male	5 26.3%
Region of Enrollment (participants) [Number]
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Survivorship of the Encore Reverse Shoulder Prosthesis
Description	Number of subjects who completed all study visits through the 1 year visit.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Encore RSP
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.
Measure Participants	13
Number [participants]	13 68.4%

Adverse Events

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.
Arm/Group Title	Encore RSP
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Encore RSP
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Encore RSP
	Affected / at Risk (%)	# Events
Total	11/19 (57.9%)
Infections and infestations
Staph infection at IV site	1/19 (5.3%)	1
Injury, poisoning and procedural complications
Multiple contusions	1/19 (5.3%)	1
Musculoskeletal and connective tissue disorders
Back and Bilateral knee pain	1/19 (5.3%)	1
Forearm and Jaw fracture	1/19 (5.3%)	1
Increased left shoulder pain	3/19 (15.8%)	3
Increased right knee pain	1/19 (5.3%)	1
Increased right shoulder pain	2/19 (10.5%)	2
Left knee pain	1/19 (5.3%)	1
Nasal fracture	1/19 (5.3%)	1
Right humeral fracture	2/19 (10.5%)	2
Right middle trigger finger pain	2/19 (10.5%)	2
Right shoulder instability	1/19 (5.3%)	1
left elbow and hand pain	1/19 (5.3%)	1
Nervous system disorders
Parkinson's Disease	1/19 (5.3%)	1
Right radial nerve palsy	1/19 (5.3%)	1
Renal and urinary disorders
Bronchitis and bladder infection	1/19 (5.3%)	1
Respiratory, thoracic and mediastinal disorders
Bilateral pulmonary emboli	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.