NCT07520721

Poly vs Hybrid Glenoid in Stemless aTSA

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Spaarne Gasthuis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glenohumeral Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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.

Timeline

• Start date: 2025-06-30
• Primary completion: 2035-07-30
• Completion: 2036-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Netherlands