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.
Study Type
OBSERVATIONAL
Enrollment
76
Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System
go:h - Gelenkchirurgie Orthopädie: Hannover
Hanover, Germany
Krankenhaus Reinbek St. Adolf-Stilt
Reinbek, Germany
ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre
Feltre, Italy
Orthopädische Klinik Luzern - OKL
Lucerne, Switzerland
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Clinical outcome: Change of shoulder function
Change of active Range of Motion (ROM)
Time frame: 5 years
Radiological outcome: Radiological implant stability
Presence of Radiolucent Lines and other radiological signs of instability
Time frame: 5 years
Radiological outcome: Radiological implant stability
Presence of Radiolucent Lines and other radiological signs of instability
Time frame: 2 years
Safety Outcome
Incidence of adverse events and complications
Time frame: 5 years
Implant survival rate
Rate of revisions. Survival estimated with Kaplan-Meier method.
Time frame: 5 years
Implant survival rate
Implant failures. Survival estimated with Kaplan-Meier method.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.