RecruitingNot ApplicableNCT05062252

Mirror Medacta Shoulder System Pivotal Trial

Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.

Sponsor

Medacta International SA

Enrollment

100 participants

Start Date

Jan 5, 2022

Study Type

INTERVENTIONAL

Conditions

The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.

Min Age: 18 Years

Age ≥ 18 yr
Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
Willingness and ability to comply with study protocol

Medical condition or balance impairment that could lead to falls
Prior rotator cuff surgery
Cuff tear arthropathy/insufficient rotator cuff
Insufficient bone quality which may affect the stability of the implant
Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
Active metastatic or neoplastic disease at the shoulder joint
Chemotherapy treatment/radiotherapy within 6 mo before surgery
\>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
Pregnancy or plan to become pregnant during study period
Inability to understand study or a history of noncompliance with medical advice
Alcohol or drug abuse
Current enrollment in any clinical research study that might interfere with this study
Metal allergies or sensitivity.
Previous or current infection at or near the site of implantation.
Current distant or systemic infection
Patient, whose infomed consent form should be taken in an emergency situation
ONLY for women of childbearing age: a positive pregnancy test (urine / blood)