Mirror Medacta Shoulder System Pivotal Trial

Medacta

Status: Enrolling

Conditions: Arthritis Shoulder; Post-traumatic Arthrosis of Other Joints, Upper Arm

Treatments: Device: Medacta Shoulder System; Device: Mirror Medacta Shoulder System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05062252

P06.003.01

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Mirror group

Experimental group

Description:

Mirror Medacta Shoulder System

Treatment:

Device: Mirror Medacta Shoulder System

Historical Control group

Active Comparator group

Description:

Total shoulder arthroplasty system

Treatment:

Device: Medacta Shoulder System