Avascular Necrosis of Humerus, Cuff Tear Arthropathy, Fracture, Shoulder, Primary Osteoarthritis, Psoriatic Arthritis, Rheumatoid Arthritis Shoulder, Secondary Osteoarthritis, Shoulder Osteoarthritis
Conditions
Keywords
Total Shoulder Arthroplasty, Shoulder Prosthesis, Observational Study, Cuff Tear Arthropathy, Shoulder Osteoarthritis
Brief summary
This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Patients requiring a revision shoulder arthroplasty will not be enrolled. The effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. The incidence of complications, adverse and serious adverse events will also be studied. Additional study aim is to evaluate a medium/long term survival of the prosthesis. The duration of the study per single subject is 5 years.
Interventions
PROCEDURETotal Shoulder Arthroplasty with Permedica's MIRAI
Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System
Sponsors
Permedica spa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome: Change of shoulder function | 5 years | Change of American Shoulder and Elbow Surgeons (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological outcome: Radiological implant stability | 5 years | Presence of Radiolucent Lines and other radiological signs of instability |
| Safety Outcome | 5 years | Incidence of adverse events and complications |
| Implant survival rate | 5 years | Rate of revisions. Survival estimated with Kaplan-Meier method. |
Countries
Germany, Italy, Switzerland
Outcome results
None listed