Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simpliciti™ Shoulder System | Experimental | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simpliciti™ Shoulder System | Device | Total shoulder arthroplasty system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | A subject is a Patient Success at 24-months if:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Simple Shoulder Test 1 (worse) - 12 (best) | 24 months |
| Range of Motion |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Lack of sufficient sound bone to seat and support the implant such as:
Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
Infection at or near the site of implantation, including:
Distant or systemic infection
Medical conditions or balance impairments that could lead to falls
Prior open shoulder surgery on the shoulder to be treated in the study including failed rotator cuff surgery, but excluding successful shoulder arthroscopy
Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
Metabolic disorders which may impair bone function
Nonfunctional deltoid muscle
Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
Female subjects who are pregnant or planning to become pregnant within the study period
In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
History of any cognitive or mental health status that would interfere with study participation
Alcohol or drug abuse
Engages in manual labor or sports activities that could affect shoulder outcome
Currently enrolled in any clinical research study that might interfere with the current study endpoints
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Agnes Medical Center | Fresno | California | 93720 | United States | ||
| Grossmont/Sharp Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Simpliciti™ Shoulder System | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. Simpliciti™ Shoulder System: Total shoulder arthroplasty system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months |
| Strength | Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier | 24 months |
| Device Parameters | Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
| 24 months |
| American Shoulder and Elbow Surgeon Score | 0 (worst) - 100 (best) | 24 Months |
| Pain: Visual Analog Scale | 0 (best) - 10 (worst) | 24 Months |
| La Mesa |
| California |
| 91942 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Rush Hospital | Chicago | Illinois | 60612 | United States |
| Beverly Hills Orthopaedic Surgery | Beverly Hills | Michigan | 48025 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Sports and Orthopaedic Specialists | Edina | Minnesota | 55439 | United States |
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
| Bassett Healthcare Network Research Institute | Cooperstown | New York | 13326 | United States |
| Cleveland Clinic | Euclid | Ohio | 44119 | United States |
| The Center | Bend | Oregon | 97701 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Knoxville Orthopaedic Clinic | Knoxville | Tennessee | 37917 | United States |
| Aurora Medical Center - Grafton | Grafton | Wisconsin | 53024 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Simpliciti™ Shoulder System | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. Simpliciti™ Shoulder System: Total shoulder arthroplasty system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Device Success Rate | A subject is a Patient Success at 24-months if:
| Posted | Number | participants | 24 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Quality of Life | Simple Shoulder Test 1 (worse) - 12 (best) | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Range of Motion |
| Posted | Mean | Standard Deviation | Degrees | 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Strength | Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier | Posted | Mean | Standard Deviation | Pounds | 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Device Parameters | Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
| Posted | Number | Percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||
| Secondary | American Shoulder and Elbow Surgeon Score | 0 (worst) - 100 (best) | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Pain: Visual Analog Scale | 0 (best) - 10 (worst) | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simpliciti™ Shoulder System | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. Simpliciti™ Shoulder System: Total shoulder arthroplasty system | 4 | 157 | 51 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aseptic Glenoid Loosening | Musculoskeletal and connective tissue disorders |
| |||
| Arthrofibrosis, treated shoulder | Musculoskeletal and connective tissue disorders |
| |||
| Infection | Infections and infestations |
| |||
| Weakness | Musculoskeletal and connective tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | OA in other joints leading to joint replacement |
| ||
| Pain | Musculoskeletal and connective tissue disorders | Not related to the study shoulder |
|
PIs are restricted from publishing study results until either 18 months after the study is completed or the primary manuscript has been accepted, whichever comes first.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josh Myers | Tornier/Wright Medical | 9529217119 | josh.myers@wright.com |
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Elevation in the Scapular Plan |
| |||||
| Internal Rotation |
| |||||
| External Rotation |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Migration |
| |||||
| Osteolysis |
| |||||
| Subsidence |
|
| Categories |
|---|
|
| Categories |
|---|
|