Clinical and Radiological Outcomes of Medacta Shoulder System

September 23, 2025 updated by: Medacta International SA
This is a post-marketing surveillance on Medacta Shoulder System

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marcq-en-Barœul, France
        • Clinique du Sport et de Chirurgie Orthopédique
  • Germany
      • München, Germany
        • Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Bern, Switzerland
        • Lindenhofspital
      • Sankt Gallen, Switzerland
        • Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3006
        • Orthopädie Sonnenhof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 10 years
Kaplan Meier method
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 10 years
record of adverse event
up to 10 years
Clinical outcome
Time Frame: 1, 2, 5 and 10 years
Constant & Murley Score
1, 2, 5 and 10 years
Functional outcome
Time Frame: 1, 2, 5 and 10 years
Oxford Shoulder Score
1, 2, 5 and 10 years
Radiographic performance of the implants
Time Frame: 3 months, 1, 2, 5 and 10 years
presence of radiolucencies
3 months, 1, 2, 5 and 10 years
Quality of life
Time Frame: 1, 2, 5 and 10 years
EQ-5D
1, 2, 5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Investigators

  • Principal Investigator: Matthias Zumstein, Prof Dr. Med, Insel Gruppe AG, University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06.001.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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