Poly vs Hybrid Glenoid in Stemless aTSA
NCT07520721 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2026-04-09
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
- 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.
Sponsors & Collaborators
-
Isala
collaborator OTHER -
Enovis
collaborator UNKNOWN -
Spaarne Gasthuis
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2035-07-30
- Completion
- 2036-12-31
Countries
- Netherlands
Study Locations
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