Post-traumatic Arthrosis of Other Joints, Upper Arm, Primary Generalized (Osteo)Arthritis
Conditions
Brief summary
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Interventions
DEVICESimpliciti™ Shoulder System
Total shoulder arthroplasty system
Sponsors
Stryker Trauma and Extremities
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subject 22 years or older * Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis. * Scapula and proximal humerus must have reached skeletal maturity * Subject with a Constant Score ≥ 20 * Willing and able to comply with the protocol * Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
Exclusion criteria
* Lack of sufficient sound bone to seat and support the implant such as: 1. Rapid joint destruction, marked bone loss or bone resorption; 2. Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and 3. Osteomalacia * 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: 1. Glenohumeral joint infection 2. Osteomyelitis * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Rate | 24 months | A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 24 months | * Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side |
| Strength | 24 months | Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier |
| Quality of Life | 24 months | Simple Shoulder Test 1 (worse) - 12 (best) |
| American Shoulder and Elbow Surgeon Score | 24 Months | 0 (worst) - 100 (best) |
| Pain: Visual Analog Scale | 24 Months | 0 (best) - 10 (worst) |
| Device Parameters | 24 months | Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: * Migration * Osteolysis * Subsidence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Simpliciti™ Shoulder System The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Simpliciti System Removal | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Simpliciti™ Shoulder System |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 157 |
| serious Total, serious adverse events | 4 / 157 |
Outcome results
Primary
Device Success Rate
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simpliciti™ Shoulder System | Device Success Rate | 134 participants |
Secondary
American Shoulder and Elbow Surgeon Score
0 (worst) - 100 (best)
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simpliciti™ Shoulder System | American Shoulder and Elbow Surgeon Score | 91.9 units on a scale | Standard Deviation 11.4 |
Secondary
Device Parameters
Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: * Migration * Osteolysis * Subsidence
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simpliciti™ Shoulder System | Device Parameters | Subsidence | 0 Percentage of participants |
| Simpliciti™ Shoulder System | Device Parameters | Migration | 0 Percentage of participants |
| Simpliciti™ Shoulder System | Device Parameters | Osteolysis | 0 Percentage of participants |
Secondary
Pain: Visual Analog Scale
0 (best) - 10 (worst)
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simpliciti™ Shoulder System | Pain: Visual Analog Scale | 0.5 units on a scale | Standard Deviation 1.2 |
Secondary
Quality of Life
Simple Shoulder Test 1 (worse) - 12 (best)
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simpliciti™ Shoulder System | Quality of Life | 10.8 units on a scale | Standard Deviation 1.7 |
Secondary
Range of Motion
* Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side
Time frame: 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simpliciti™ Shoulder System | Range of Motion | Elevation in the Scapular Plan | 146.6 Degrees | Standard Deviation 23.7 |
| Simpliciti™ Shoulder System | Range of Motion | Internal Rotation | 73.9 Degrees | Standard Deviation 1635 |
| Simpliciti™ Shoulder System | Range of Motion | External Rotation | 56.4 Degrees | Standard Deviation 15.4 |
Secondary
Strength
Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simpliciti™ Shoulder System | Strength | 15.7 Pounds | Standard Deviation 7.8 |