Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

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

NCT05002335

P06.001.05

Details and patient eligibility

About

This is a post-market surveillance study 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:

  1. Primary osteoarthritis
  2. Secondary osteoarthritis
  3. Cuff tear arthropathy; insufficient rotator cuff
  4. Acute fracture (<21d)
  5. Rheumatoid or inflammatory arthritis
  6. Avascular necrosis
  7. Other posttraumatic condition
  8. 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)