Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

NCT ID: NCT05002335

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

2020-10-06

Study Completion Date

2027-12-31

Brief Summary

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This is a post-market surveillance study 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

Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System

Intervention Type DEVICE

Eligibility Criteria

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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)
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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Bart Berghs, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan (Brugge, Belgium)

Locations

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AZ Sint-Jan

Bruges, , Belgium

Site Status

AZ Sint-Lucas

Bruges, , Belgium

Site Status

Clinique St-Luc Bouge

Namur, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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P06.001.05

Identifier Type: -

Identifier Source: org_study_id

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