RecruitingNot ApplicableNCT07520721

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

Sponsor

Spaarne Gasthuis

Enrollment

94 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Glenohumeral Osteoarthritis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of shoulder socket components used in total shoulder replacement surgery for people with shoulder osteoarthritis: a traditional all-plastic (polyethylene) component and a newer hybrid titanium-based component. The goal is to determine which type performs better over time in terms of pain relief, function, and durability. Adults aged 18 or older with symptomatic shoulder osteoarthritis of at least one year who have not responded to non-surgical treatment and require primary shoulder replacement may be eligible. Participation involves being randomly assigned to receive one of the two implant types during surgery, then attending follow-up visits to assess outcomes. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAnatomic 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).

PROCEDUREAnatomic 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

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NCT07520721

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