Poly vs Hybrid Glenoid in Stemless aTSA (NCT07520721) | Clinical Trial Compass
RecruitingNot Applicable
Poly vs Hybrid Glenoid in Stemless aTSA
Netherlands94 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Both genders;
✓. Age 18 years old;
✓. Life expectancy over 5 years;
✓. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;
✓. Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based on physical examination, medical history and X ray examination. (In cases where bilateral aTSA's are indicated, the patient will be included for the second aTSA again when the patient meets the inclusion criteria);
✓. Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;
✓. A diagnosis in the target shoulder of osteoarthritis; according to the classification of Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 degrees.
✓. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;