New shoulder implant could improve joint replacement outcomes
NCT ID NCT07520721
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of glenoid implants used in total shoulder replacement for patients with shoulder osteoarthritis. Half of the 94 participants will receive a standard cemented plastic implant, while the other half will receive a new hybrid implant with a titanium central peg designed to promote bone growth. Researchers will measure shoulder function and pain over time to see if the new implant works as well as the standard one.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shoulder replacement surgery with either a standard cemented plastic glenoid implant or a hybrid implant with a titanium central peg
- What this could lead to
- If the hybrid implant works as well as the standard one, it may offer an alternative option for shoulder replacement that could potentially improve implant stability over time.
- What could go wrong
- This is a relatively small trial (94 participants) comparing two surgical implants. It is not testing a new drug or cure, and results may not apply to all patients. There are standard surgical risks like infection or implant loosening.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Both genders; 2. Age 18 years old; 3. Life expectancy over 5 years; 4. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments; 5. 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); 6. Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation; 7. 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. 8. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent; 9. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee. Exclusion Criteria: 1. Patient requiring revision shoulder arthroplasty; 2. Osteoporosis with a history of non-traumatic fractures; 3. Steroid injections within the previous 6 months; 4. Contralateral shoulder replacement within the previous 3 months; 5. Meta-epiphyseal bony defect (including large cysts); 6. Significant proven or suspicious infection of the target shoulder or any serious infectious disease 7. Significant neurological or musculoskeletal disorders that may compromise functional recovery; 8. Known or suspicious hypersensitivity to the metal or other materials of the implant; 9. 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; 10. Any systemic disease which may affect outcome. 11. Active or metastatic neoplastic disease 12. Chemotherapy and/or radiotherapy within the last 6 months 13. Previous organ transplant 14. Participation in any clinical research study that may interfere with this study 15. A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder. 16. Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder. 17. Imminent suicide risk. 18. Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spaarne Gasthuis
RECRUITINGHoofddorp, North Holland, 2134 TM, Netherlands
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Other studies related to the condition(s) this trial covers.
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