Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Permedica spa
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
both genders
at least 18 years old of age
undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed).
Signed informed consent
You may not be if
Patients requiring a revision shoulder arthroplasty
Persistent chronic or acute infections and all septic conditions
Persistent osteomyelitis local or systemic
Allergy or hypersensitivity to the substances contained in the materials of the implanted components
Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle
Inadequate bone structure which cannot guarantee stability to the prosthetic components
Several vascular, nerve or muscular disorders, which compromise related extremities
Marked osteoporosis, osteomalacia
Hypotrophy of the periarticular soft tissues
Dysmetabolic diseases such as, for example, kidney failure or systemic diseases
Muscular insufficiency
Active neoplastic or metastatic diseases
Any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability
Patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits
Women in pregnancy, childbearing potential or breastfeeding
Involvement in other ongoing studies or clinical trial.
Clareo Health | Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
