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

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05128500
• Other study ID #: MIRAI CLH-1
• Status: Active, not recruiting
• Start date: July 12, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Permedica spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Avascular Necrosis of Humerus
• Cuff Tear Arthropathy
• Fracture, Shoulder
• Joint Diseases
• Necrosis
• Osteoarthritis
• Primary Osteoarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis Shoulder
• Rotator Cuff Tear Arthropathy
• Secondary Osteoarthritis
• Shoulder Fractures
• Shoulder Osteoarthritis

Intervention

Procedure:
• Total Shoulder Arthroplasty with Permedica's MIRAI
Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Permedica spa

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Clinical outcome: Change of shoulder function	Change of active Range of Motion (ROM)	5 years
Secondary	Radiological outcome: Radiological implant stability	Presence of Radiolucent Lines and other radiological signs of instability	5 years
Secondary	Radiological outcome: Radiological implant stability	Presence of Radiolucent Lines and other radiological signs of instability	2 years
Secondary	Safety Outcome	Incidence of adverse events and complications	5 years
Secondary	Implant survival rate	Rate of revisions. Survival estimated with Kaplan-Meier method.	5 years
Secondary	Implant survival rate	Implant failures. Survival estimated with Kaplan-Meier method.	2 years