Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.

Official Title
-----------------
Simpliciti IDE Trial

Conditions
-----------------
Primary Generalized (Osteo)Arthritis, Post-traumatic Arthrosis of Other Joints, Upper Arm

Intervention / Treatment
-----------------
* Device: Simpliciti™ Shoulder System


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Rapid joint destruction, marked bone loss or bone resorption; Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and 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: Glenohumeral joint infection 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simpliciti™ Shoulder System<br>The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. | Device: Simpliciti™ Shoulder System<br>* Total shoulder arthroplasty system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success Rate | A subject is a Patient Success at 24-months if: There is NO continuous radiolucent line around the prosthesis; and The adjusted Constant Score is > 85 (successful outcome); and They did not have revision surgery; and They did not have a system-related serious adverse event. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Simple Shoulder Test 1 (worse) - 12 (best) | 24 months | 
| Range of Motion | Elevation in the scapula plane Internal rotation with arm at the side External rotation with arm at the side | 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: Migration Osteolysis Subsidence | 24 months | 
| American Shoulder and Elbow Surgeon Score | 0 (worst) - 100 (best) | 24 Months | 
| Pain: Visual Analog Scale | 0 (best) - 10 (worst) | 24 Months |