An interventional study of Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid and Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid in Glenohumeral Osteoarthritis, sponsored by Spaarne Gasthuis. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Spaarne Gasthuis · Not applicable, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 94 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Spaarne Gasthuis is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid.
Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid
Hybrid trabecular titanium central-peg glenoid
Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).
Also known as: Cemented polyethylene glenoid component
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.
Constant-Murley Score (shoulder function)
Clinical shoulder function assessed with the Constant-Murley Score (absolute and age/sex-adjusted) comparing hybrid versus standard glenoid fixation after anatomic total shoulder arthroplasty. The Constant-Murley Score ranges from 0 to 100 points, with 0 indicating the worst outcome and 100 indicating the best shoulder function.
Time frame: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Shoulder range of motion
Active shoulder range of motion (e.g., forward flexion, abduction, external/internal rotation) assessed clinically to compare recovery between glenoid groups.
Time frame: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Oxford Shoulder Score questionnaire
Patient-reported shoulder pain and function measured with the Oxford Shoulder Score, comparing both glenoid fixation concepts. The Oxford Shoulder Score ranges from 0 to 48 points, with higher scores indicating a better outcome / better shoulder function. This is inferred from the 12-item questionnaire with 5 response options per item shown in the uploaded form.
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Hospital Anxiety subscale questionnaire
Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-D), a 7-item subscale of the full questionnaire. The Hospital Anxiety and Depression Scale is generally interpreted per subscale rather than as a single total score. The Anxiety and Depression subscales are assessed separately, each ranging from 0 to 21 points, with higher scores indicating more symptoms and therefore a worse outcome.
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Hospital Depression subscale questionnaire
Depressive symptoms assessed with the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), a 7-item subscale of the full questionnaire. The Hospital Anxiety and Depression Scale is generally interpreted per subscale rather than as a single total score. The Anxiety and Depression subscales are assessed separately, each ranging from 0 to 21 points, with higher scores indicating more symptoms and therefore a worse outcome.
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Subjective Shoulder Value Scale
Patient-rated shoulder function as a percentage of normal (0-100%), comparing treatment arms. The Subjective Shoulder Value ranges from 0% to 100%, with higher percentages indicating better perceived shoulder function.
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Health-related quality of life - EuroQol-5D descriptive system
Health-related quality of life assessed with the EuroQol-5D descriptive system, which includes five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-level scale ranging from no problems to extreme problems. The combination of responses across the five domains is used to generate one overall health-state profile rather than a simple summed total score.
Time frame: Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.
Health-related quality of life - EuroQol-5D Visual Analogue Scal
Generic quality-of-life measured with the EQ-5D to compare overall health status between study arms.The EQ-5D visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health.
Time frame: Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.
Work-Related Questionnaire for Upper Extremity Disorders
Work limitations related to upper-extremity function assessed with the WRFQ-UE. The WorkQ-up consists of 17 items scored from 0 to 5 (or marked not applicable), resulting in a total score range of 0 to 85 if all items are applicable, with higher scores indicating more difficulty at work and therefore a worse outcome.
Time frame: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.
Work Ability (single-item Work Ability Score) numeric scale
Self-rated work ability assessed with a single-item Work Ability Score to evaluate work capacity over time. The Work Ability Score ranges from 0 to 10 points, with higher scores indicating better work ability and therefore a better outcome.
Time frame: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.
Implant survival (radiographic loosening endpoint)
Time-to-event implant survival where failure is defined as radiographic loosening and/or revision as specified in the protocol; compared between arms.
Time frame: Up to 10 years postoperatively.
Number of implant-related complications
Number of implant-related complications recorded from surgery through 10 years postoperatively.
Time frame: From surgery through 10 years postoperatively.
Number of non-implant-related complications
Number of non-implant-related complications recorded from surgery through 10 years postoperatively.
Time frame: From surgery through 10 years postoperatively.
Number of implant-related adverse events
Number of implant-related adverse events recorded from surgery through 10 years postoperatively.
Time frame: From surgery through 10 years postoperatively.
Number of non-implant-related adverse events
Number of non-implant-related adverse events recorded from surgery through 10 years postoperatively.
Time frame: From surgery through 10 years postoperatively.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — De-identified IPD will not be shared because the protocol does not include an IPD-sharing plan and participant data are handled as coded personal data under GDPR/AVG with access restricted to authorized study personnel; any data transfer is limited to protocol-defined purposes (e.g., publication support).
Started Jun 2025 (actual). Primary completion is estimated for Jul 2035, 121 months after the start.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 121 months is above that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
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Spaarne Gasthuis