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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Psoriatic Arthritis; Shoulder Osteoarthritis; Primary Osteoarthritis; Secondary Osteoarthritis; Avascular Necrosis of Humerus; Rheumatoid Arthritis Shoulder; Cuff Tear Arthropathy; Fracture, Shoulder
• Intervention / Treatment: Procedure: Total Shoulder Arthroplasty with Permedica's MIRAI

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Simona Mancini; Phone Number: 00390399514811; Email: simona.mancini@permedica.it

Study Locations

• Germany
  • Hanover, Germany
    • go:h - Gelenkchirurgie Orthopädie: Hannover
  • Reinbek, Germany
    • Krankenhaus Reinbek St. Adolf-Stilt
• Italy
  • Feltre, Italy, 32032
    • ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre
• Switzerland
  • Luzern, Switzerland
    • Orthopädische Klinik Luzern - OKL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Permedica spa
• Investigators: Study Director: Lorenzo Banci, Permedica

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Observational Study; Total Shoulder Arthroplasty; Cuff Tear Arthropathy; Shoulder Prosthesis; Shoulder Osteoarthritis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Shoulder Injuries; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Crystal Arthropathies; Chondrocalcinosis; Arthritis; Osteoarthritis; Joint Diseases; Necrosis; Arthritis, Psoriatic; Shoulder Fractures; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: MIRAI CLH-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No