Poly vs Hybrid Glenoid in Stemless aTSA
Recruiting · NCT07520721 · Interventional (participants receive a specific treatment) · Lead sponsor: Spaarne Gasthuis
View the official record on ClinicalTrials.gov →Interventions studied
Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoidAnatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 included for the second aTSA again when the patient meets the inclusion criteria);
- 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.
Exclusion criteria
- 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 study;
- 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
Where it is running
1 location listed.
- Spaarne Gasthuis - Hoofddorp, North Holland, Netherlands