Clinical and Radiological Outcomes of Medacta Shoulder System

Medacta

Status: Active, not recruiting

Conditions: Secondary Osteoarthritis; Rheumatoid Arthritis Shoulder; Fracture; Revision of Shoulder Arthroplasty; Avascular Necrosis; Rotator Cuff Tear Arthropathy; Primary Osteoarthritis

Treatments: Device: Medacta Shoulder System

Study type: Observational

Funder types: Industry

Identifiers

NCT03547947

P06.001.01

Details and patient eligibility

About

This is a post-marketing surveillance on Medacta Shoulder System

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years
• Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion criteria

• Patients with malignant diseases (at the time of surgery)
• Patients with proven or suspect infections (at the time of surgery)
• Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
• Patients with known incompatibility or allergy to products materials (at the time of surgery)