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NCT Number: NCT05128500

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

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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Key information

Conditions

Cuff Tear Arthropathy Arthritis Arthritis, Psoriatic Avascular Necrosis of Humerus Bone Diseases Chondrocalcinosis Crystal Arthropathies Fracture, Shoulder Fractures, Bone Joint Diseases Musculoskeletal Diseases Primary Osteoarthritis Psoriasis Psoriatic Arthritis Rheumatoid Arthritis Shoulder Rotator Cuff Tear Arthropathy Secondary Osteoarthritis Shoulder Fractures Shoulder Injuries Shoulder Osteoarthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

go:h - Gelenkchirurgie Orthopädie: Hannover, Hanover, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Shoulder Arthroplasty with Permedica's MIRAI

Procedure

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

Primary outcomes

  1. Clinical outcome: Change of shoulder function

    Time frame: 5 years

    Change of "American Shoulder and Elbow Surgeons" (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.

  2. Clinical outcome: Change of shoulder function

    Time frame: 5 years

    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.

  3. Clinical outcome: Change of shoulder function

    Time frame: 5 years

    Change of Constant Score. Total score 0-100 Constant points, 0 = worse outcome and functional loss/disability; 100 = better outcome, shoulder function improvement.

  4. Clinical outcome: Change of shoulder function

    Time frame: 5 years

    Change of active Range of Motion (ROM)

Secondary outcomes

  1. Radiological outcome: Radiological implant stability

    Time frame: 5 years

    Presence of Radiolucent Lines and other radiological signs of instability

  2. Radiological outcome: Radiological implant stability

    Time frame: 2 years

    Presence of Radiolucent Lines and other radiological signs of instability

  3. Safety Outcome

    Time frame: 5 years

    Incidence of adverse events and complications

  4. Implant survival rate

    Time frame: 5 years

    Rate of revisions. Survival estimated with Kaplan-Meier method.

  5. Implant survival rate

    Time frame: 2 years

    Implant failures. Survival estimated with Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

Permedica spa

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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