Poly vs Hybrid Glenoid in Stemless aTSA

Trial details

Who runs it

Spaarne Gasthuis

Trial code

NCT07520721

Record updated

9 April 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: -; In order to be eligible to participate in this study, a subject must meet all of the following 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; Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

Exclusion: Steroid injections within the previous 6 months; Contralateral shoulder replacement within the previous 3 months; Chemotherapy and/or radiotherapy within the last 6 months; Previous organ transplant; A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder; Osteoporosis with a history of non-traumatic fractures; Significant proven or suspicious infection of the target shoulder or any serious infectious disease; Significant neurological or musculoskeletal disorders that may compromise functional recovery; Known or suspicious hypersensitivity to the metal or other materials of the implant; Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study; Any systemic disease which may affect outcome; Active or metastatic neoplastic disease; Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder; Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment; Patient requiring revision shoulder arthroplasty; Meta-epiphyseal bony defect (including large cysts); Participation in any clinical research study that may interfere with this study; Imminent suicide risk.

ClinicalTrials.gov NCT07520721