Status:

ENROLLING_BY_INVITATION

Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

Lead Sponsor:

Materialise

Conditions:

Arthroplasty, Replacement, Shoulder

Glenoid Cavity

Eligibility:

All Genders

18+ years

Brief Summary

This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction syste...

Detailed Description

The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these...

Eligibility Criteria

Inclusion

  • patients having primary or revision shoulder joint replacement with severe glenoid bone defects
  • Patient is 18 years of age or older
  • Patient can follow the Glenius system procedure that is standard of care
  • Patient is willing to cooperate in the required post-operative therapy
  • Patient has participated in the informed consent process and has signed the EC approved informed consent form

Exclusion

  • Pregnant patients
  • Skeletally immature patients
  • Prisoners

Key Trial Info

Start Date :

July 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03806881

Start Date

July 1 2019

End Date

December 1 2028

Last Update

March 13 2024

Active Locations (4)

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Page 1 of 1 (4 locations)

1

AZ St-Elisabeth

Herentals, Belgium

2

University Hospital Leuven - Traumatology

Leuven, Belgium, 3000

3

University Hospital Leuven - Orthopedics

Leuven, Belgium

4

Sint-Maartenskliniek

Nijmegen, Netherlands