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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encore Reverse Shoulder Prosthesis | Device | rotator cuff deficiency and glenohumeral arthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of the Encore Reverse Shoulder Prosthesis | Number of subjects who completed all study visits through the 1 year visit. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| J. Michael Kioschos, M.D. | Nashville Orthopedic Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nashville Orthopedic Specialists | Nashville | Tennessee | 37203 | United States |
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| Label | URL |
|---|---|
| Sponsor Company home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survivorship of the Encore Reverse Shoulder Prosthesis | Number of subjects who completed all study visits through the 1 year visit. | Posted | Number | participants | 1 year |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back and Bilateral knee pain | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane M. Jacob - Manager of Clinical Affairs | DJO Surgical | 512-834-6323 | jane.jacob@djosurgical.com |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 0 |
| 19 |
| 11 |
| 19 |
| Bilateral pulmonary emboli | Respiratory, thoracic and mediastinal disorders |
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| Bronchitis and bladder infection | Renal and urinary disorders |
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| Forearm and Jaw fracture | Musculoskeletal and connective tissue disorders |
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| Increased left shoulder pain | Musculoskeletal and connective tissue disorders |
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| Increased right knee pain | Musculoskeletal and connective tissue disorders |
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| Increased right shoulder pain | Musculoskeletal and connective tissue disorders |
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| Left knee pain | Musculoskeletal and connective tissue disorders |
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| Multiple contusions | Injury, poisoning and procedural complications |
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| Nasal fracture | Musculoskeletal and connective tissue disorders |
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| Parkinson's Disease | Nervous system disorders |
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| Right humeral fracture | Musculoskeletal and connective tissue disorders |
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| Right middle trigger finger pain | Musculoskeletal and connective tissue disorders |
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| Right radial nerve palsy | Nervous system disorders |
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| Right shoulder instability | Musculoskeletal and connective tissue disorders |
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| Staph infection at IV site | Infections and infestations |
|
| left elbow and hand pain | Musculoskeletal and connective tissue disorders |
|
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