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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Shoulder Arthroplasty with Permedica's MIRAI | Procedure | Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are about to undergo a primary total shoulder arthroplasty in daily clinical practice, referring to one of the project investigator at the study site will be proposed to partecipate to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Banci | Permedica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| go:h - Gelenkchirurgie Orthopädie: Hannover | Hanover | Germany | ||||
| Krankenhaus Reinbek St. Adolf-Stilt |
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| 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 |
| Reinbek |
| Germany |
| ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre | Feltre | 32032 | Italy |
| Orthopädische Klinik Luzern - OKL | Lucerne | Switzerland |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| D015535 | Arthritis, Psoriatic |
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D000072228 | Arthroplasty, Replacement, Shoulder |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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