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Compares treatment options for Glenohumeral Osteoarthritis
Official title Poly vs Hybrid Glenoid in Stemless aTSA
ClinicalTrials.gov ID: NCT07520721
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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;
You likely can't join if
- 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;
- Meta-epiphyseal bony defect (including large cysts);
- Significant proven or suspicious infection of the target shoulder or any serious infectious disease
See the full eligibility criteria
- \- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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;
- 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...
- Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;
- 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.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.
- 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;
- Meta-epiphyseal bony defect (including large cysts);
- Significant proven or suspicious infection of the target shoulder or any serious infectious disease
- Significant neurological or musculoskeletal disorders that may compromise functional recovery;
- Known or suspicious hypersensitivity to the metal or other materials of the implant;
- 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...
- Any systemic disease which may affect outcome.
- Active or metastatic neoplastic disease
- Chemotherapy and/or radiotherapy within the last 6 months
- Previous organ transplant
- Participation in any clinical research study that may interfere with this study
- A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.
- Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder.
- Imminent suicide risk.
- Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment
The study team makes the final eligibility decision.
Where it's taking place
- Hoofddorp, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hoofddorp, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.