Glenohumeral Arthritis Clinical Trial
Official title:
Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
Verified date | August 2010 |
Source | Encore Medical, L.P. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Nashville Orthopedic Specialists | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Encore Medical, L.P. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survivorship of the Encore Reverse Shoulder Prosthesis | Number of subjects who completed all study visits through the 1 year visit. | 1 year | No |
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