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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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