Clinical and Radiological Outcomes of Medacta Shoulder System

NCT03547947 | Active Not Recruiting

• 1 other identifier: P06.001.01
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 6

Brief Summary

This is a post-marketing surveillance on Medacta Shoulder System

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Kaplan Meier method

  10 years

Secondary Outcomes (5)

• Clinical outcome

  1, 2, 5 and 10 years

• Functional outcome

  1, 2, 5 and 10 years

• Radiographic performance of the implants

  3 months, 1, 2, 5 and 10 years

• Quality of life

  1, 2, 5 and 10 years

• Adverse events

  up to 10 years

Interventions

Medacta Shoulder System DEVICE

Total Shoulder Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (6)

Clinique du Sport et de Chirurgie Orthopédique

Marcq-en-Barœul, France

Location

Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation

München, Germany

Location

Orthopädie Sonnenhof

Bern, Canton of Bern, 3006, Switzerland

Location

Inselspital

Bern, Switzerland

Location

Lindenhofspital

Bern, Switzerland

Location

Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Osteonecrosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Matthias Zumstein, Prof Dr. Med

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: June 13, 2018
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4); FR (1); DE (1)