Clinical trial NCT05128500: Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
Official title: Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cuff Tear Arthropathy
Primary Osteoarthritis
Secondary Osteoarthritis
Shoulder Osteoarthritis
Rheumatoid Arthritis Shoulder
Psoriatic Arthritis
Fracture, Shoulder
Avascular Necrosis of Humerus
Keywords: Total Shoulder Arthroplasty
Shoulder Prosthesis
Observational Study
Cuff Tear Arthropathy
Shoulder Osteoarthritis
Lead sponsor: Permedica spa
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical outcome: Change of shoulder function
timeFrame: 5 years
measure: Clinical outcome: Change of shoulder function
timeFrame: 5 years
measure: Clinical outcome: Change of shoulder function
timeFrame: 5 years
measure: Clinical outcome: Change of shoulder function
timeFrame: 5 years
Secondary outcomes:
measure: Radiological outcome: Radiological implant stability
timeFrame: 5 years
measure: Radiological outcome: Radiological implant stability
timeFrame: 2 years
measure: Safety Outcome
timeFrame: 5 years
measure: Implant survival rate
timeFrame: 5 years
measure: Implant survival rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: go:h - Gelenkchirurgie Orthopädie: Hannover
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek St. Adolf-Stilt
city: Feltre
country: Italy
facility: ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre
city: Luzern
country: Switzerland
facility: Orthopädische Klinik Luzern - OKL
Study officials:
affiliation: Permedica
name: Lorenzo Banci
role: STUDY_DIRECTOR
References: