Poly vs Hybrid Glenoid in Stemless aTSA
ConditionGlenohumeral Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpaarne Gasthuis
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Patient requiring revision shoulder arthroplasty;
Osteoporosis with a history of non-traumatic fractures;
Steroid injections within the previous 6 months;
Contralateral shoulder replacement within the previous 3 months;
Trial design
Treatments tested in this trial
- Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid
- Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
Treatment groups
94 Participants
are divided into 2 treatment groupsLocations
1Spaarne Gasthuis2134 TM, HoofddorpNorth Holland, Netherlands
Sponsors and collaborators
Spaarne Gasthuis
Lead sponsor
Isala
Collaborator
Enovis
Collaborator
Source ClinicalTrials.gov