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

NCT05128500 | Completed

• 1 other identifier: MIRAI CLH-1
• Study Type: observational
• Target: 76
• Locations: 3 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Radiological outcome: Radiological implant stability

  5 years

• Radiological outcome: Radiological implant stability

  2 years

• Safety Outcome

  5 years

• Implant survival rate

  5 years

• Implant survival rate

  2 years

Interventions

Total Shoulder Arthroplasty with Permedica's MIRAI PROCEDURE

Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Permedica spa: lead

Study Sites (4)

go:h - Gelenkchirurgie Orthopädie: Hannover

Hanover, Germany

Location

Krankenhaus Reinbek St. Adolf-Stilt

Reinbek, Germany

Location

ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre

Feltre, 32032, Italy

Location

Orthopädische Klinik Luzern - OKL

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Arthritis, Psoriatic; Shoulder Fractures

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Lorenzo Banci

  Permedica

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 22, 2021
• Study Start: July 12, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

IT (1); DE (2); CH (1)