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The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary | Experimental | Primary shoulder |
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| Revision | Experimental | Revision shoulder |
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| Continued Access | Experimental | Primary shoulder subjects enrolled at a later date in order to collect more data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse Shoulder Prosthesis | Device | For subjects with rotator cuff arthropathy and no previous shoulder device implanted. |
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| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score | The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: [(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score] | 2-year |
| Average Range of Motion | Physician's assessment of a subject's range of motion in degrees. | 2-year |
| Subject Satisfaction With Surgery | Each subject had a chance to rate their satisfaction with surgery at each study interval. | 2-year |
| Have Surgery Again? | Subject satisfaction: subject's willingness to have surgery performed again if necessary. | 2-year |
| Neer's "Limited Goals" | To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation. | 2-year |
| Radiographic Failures | Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Frankle, M.D. | Florida Orthopedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Orthopedics and Sports Medicine | Glendale | California | 91206 | United States | ||
| Orthopaedic Specialty Institute |
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| Label | URL |
|---|---|
| Sponsor company home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary | Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. |
| FG001 | Revision |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Reverse Shoulder Prosthesis | Device | For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant. |
|
| Post-operative, 3-month, 6-month, 1-year, 2-year |
| Safety Assessment | Number of device related adverse events and device failures at the 2 year time frame. | 2-year |
| Orange |
| California |
| 92868 |
| United States |
| University of Colorado | Denver | Colorado | 80054 | United States |
| Orthopedic Center of the Rockies | Fort Collins | Colorado | 80525 | United States |
| Advanced Orthopedic and Sports Medicine Specialists, P.C. | Lonetree | Colorado | 80124 | United States |
| Steadman Hawkins SPT Medical Foundation | Vail | Colorado | 81657 | United States |
| Atlantis Orthopaedics | Atlantis | Florida | 33462 | United States |
| Orthopaedic Surgery & Sports Medicine | Jupiter | Florida | 33458 | United States |
| Palm Beach Orthopaedic Institute | Palm Beach Gardens | Florida | 33410 | United States |
| Florida Orthopedic Institute | Temple Terrace | Florida | 33637 | United States |
| Atlanta | Georgia | 30342 | United States |
| Cincinnati Sports Medicine & Orthopaedic Center | Crestview | Kentucky | 41017 | United States |
| Lutherville | Maryland | 21093 | United States |
| Orthopedic Specialists | Towson | Maryland | 21204 | United States |
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| Crystal Clinic | Akron | Ohio | 44333 | United States |
| Bone & Joint Hospital, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| Orthopedic Research Foundation of the Carolinas | Spartanburg | South Carolina | 29307 | United States |
| The Carrell Clinic | Dallas | Texas | 75231 | United States |
| Orthopedic Associates of Dallas | Dallas | Texas | 75246 | United States |
| Orthopedic Specialty Associates, P.A. | Fort Worth | Texas | 76104 | United States |
| Unlimited Research | San Antonio | Texas | 78217 | United States |
| Orthopedic Institute | Tyler | Texas | 75701 | United States |
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.
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary | Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Operative Shoulder | Number | participants |
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| 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 | American Shoulder and Elbow Surgeons Shoulder Score | The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: [(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score] | The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit. | Posted | Mean | Standard Deviation | Units on a scale | 2-year |
|
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| Primary | Average Range of Motion | Physician's assessment of a subject's range of motion in degrees. | The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit. | Posted | Mean | Standard Deviation | Angle of Degrees of Shoulder Motion | 2-year |
| |||||||||||||||||||||||||||||||||
| Primary | Subject Satisfaction With Surgery | Each subject had a chance to rate their satisfaction with surgery at each study interval. | The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit. | Posted | Number | participants | 2-year |
| ||||||||||||||||||||||||||||||||||
| Primary | Have Surgery Again? | Subject satisfaction: subject's willingness to have surgery performed again if necessary. | The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit. | Posted | Number | participants | 2-year |
| ||||||||||||||||||||||||||||||||||
| Primary | Neer's "Limited Goals" | To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation. | The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit. | Posted | Number | participants | 2-year |
| ||||||||||||||||||||||||||||||||||
| Primary | Radiographic Failures | Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis. | Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam. | Posted | Number | participants | Post-operative, 3-month, 6-month, 1-year, 2-year |
| ||||||||||||||||||||||||||||||||||
| Primary | Safety Assessment | Number of device related adverse events and device failures at the 2 year time frame. | Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues. | Posted | Number | adverse events | 2-year |
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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 | Primary | Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. | 0 | 156 | 116 | 156 | ||
| EG001 | 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. | 0 | 162 | 113 | 162 | ||
| EG002 | 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. | 0 | 249 | 157 | 249 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia / Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Broken Device / Component | Surgical and medical procedures | Systematic Assessment |
| ||
| Broken Screw | Surgical and medical procedures | Systematic Assessment | screws are used to secure parts of the device to bone and will occasionally break. |
| |
| Cancer | Immune system disorders | Systematic Assessment |
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| Death - Natural Causes | Social circumstances | Systematic Assessment |
| ||
| Device Instability / Failure | Surgical and medical procedures | Systematic Assessment | Device became unstable or failed which required a revision surgery. |
| |
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Edema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heart Complications | Cardiac disorders | Systematic Assessment |
| ||
| Infections | Infections and infestations | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neurological disorder and numbness | Nervous system disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| Swelling | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Affairs | DJO Surgical | 512-832-9500 | 6323 | jane.jacob@djosurgical.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Left |
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