Clinical and Radiological Outcomes of Medacta Shoulder System

NCT ID: NCT03547947

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2031-04-30

Brief Summary

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This is a post-marketing surveillance on Medacta Shoulder System

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Medacta Shoulder System

Total Shoulder Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Zumstein, Prof Dr. Med

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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Clinique du Sport et de Chirurgie Orthopédique

Marcq-en-Barœul, , France

Site Status

Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation

München, , Germany

Site Status

Orthopädie Sonnenhof

Bern, Canton of Bern, Switzerland

Site Status

Inselspital

Bern, , Switzerland

Site Status

Lindenhofspital

Bern, , Switzerland

Site Status

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

Sankt Gallen, , Switzerland

Site Status

Countries

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France Germany Switzerland

Other Identifiers

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P06.001.01

Identifier Type: -

Identifier Source: org_study_id

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