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Poly vs Hybrid Glenoid in Stemless aTSA
Sponsor: Spaarne Gasthuis
Summary
Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.
Official title: A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2025-06-30
Completion Date
2036-12
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid
Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).
Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
Stemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs.
Locations (1)
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands