Actively Recruiting
Poly vs Hybrid Glenoid in Stemless aTSA
Led by Spaarne Gasthuis · Updated on 2026-04-09
94
Participants Needed
1
Research Sites
596 weeks
Total Duration
On this page
Sponsors
S
Spaarne Gasthuis
Lead Sponsor
I
Isala
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Poly vs Hybrid Glenoid in Stemless aTSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both genders
- Age 18 years old or older
- Life expectancy over 5 years
- Symptomatic shoulder osteoarthritis for more than 1 year
- Previous non-surgical conservative treatments tried
- Requiring primary unilateral or staged bilateral anatomic shoulder arthroplasty
- Good bone quality based on risk factors and intraoperative evaluation
- Glenoid type A1, A2, or B1 according to Walch classification with retroversion less than 15 degrees
- Willing and able to complete scheduled follow-up evaluations
- Signed informed consent form approved by Ethics Committee
You will not qualify if you...
- Need for revision shoulder arthroplasty
- Osteoporosis with history of non-traumatic fractures
- Steroid injections in the last 6 months
- Contralateral shoulder replacement in the last 3 months
- Large meta-epiphyseal bony defects including cysts
- Proven or suspected infection of the target shoulder or serious infections
- Significant neurological or musculoskeletal disorders affecting recovery
- Known or suspected allergy to implant materials
- Inability or unwillingness to comply with rehabilitation and follow-up visits
- Psychiatric illness preventing study comprehension
- Systemic diseases that could affect outcomes
- Active or metastatic cancer
- Chemotherapy or radiotherapy in last 6 months
- Previous organ transplant
- Participation in other clinical studies interfering with this study
- Current or prior serious psychiatric diagnoses including schizophrenia or bipolar disorder
- Current substance use disorder (except nicotine/tobacco) or severe alcohol use disorder
- Imminent suicide risk
- Other psychiatric conditions making study participation unsuitable per physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2134 TM
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here