Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study

Conditions
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Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis, Shoulder Osteoarthritis, Rheumatoid Arthritis Shoulder, Psoriatic Arthritis, Fracture, Shoulder, Avascular Necrosis of Humerus

Intervention / Treatment
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* Procedure: Total Shoulder Arthroplasty with Permedica's MIRAI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Shoulder Arthroplasty with Permedica's MIRAI|Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: Change of shoulder function | Change of American Shoulder and Elbow Surgeons (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability. | 5 years | 
| Clinical outcome: Change of shoulder function | Change of Disabilities of the Arm, Shoulder and Hand (DASH) Score. A higher score indicates greater disability. DASH disability/symptom score = [(sum of n responses) - 1]/n x 25, where n is equal to the number of completed responses. | 5 years | 
| Clinical outcome: Change of shoulder function | Change of Constant Score. Total score 0-100 Constant points, 0 = worse outcome and functional loss/disability; 100 = better outcome, shoulder function improvement. | 5 years | 
| Clinical outcome: Change of shoulder function | Change of active Range of Motion (ROM) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological outcome: Radiological implant stability | Presence of Radiolucent Lines and other radiological signs of instability | 5 years | 
| Radiological outcome: Radiological implant stability | Presence of Radiolucent Lines and other radiological signs of instability | 2 years | 
| Safety Outcome | Incidence of adverse events and complications | 5 years | 
| Implant survival rate | Rate of revisions. Survival estimated with Kaplan-Meier method. | 5 years | 
| Implant survival rate | Implant failures. Survival estimated with Kaplan-Meier method. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Shoulder Arthroplasty, Shoulder Prosthesis, Observational Study, Cuff Tear Arthropathy, Shoulder Osteoarthritis