Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stryker Trauma and Extremities
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
