PRIMA EU Retrospective & Prospective (NCT06371833) | Clinical Trial Compass
RecruitingNot Applicable
PRIMA EU Retrospective & Prospective
Italy60 participantsStarted 2024-10-25
Plain-language summary
This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old;
✓. Full skeletal maturity;
✓. Life expectancy over 24 months;
✓. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;
✓. Patient meets at least one of the following indications:
✓. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
✓. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.
Exclusion criteria
✕. Patients who lack capacity to be able to provide informed consent to participate in the study.
✕. Local or systemic general infection;
✕. Septicaemia;
✕. Persistent acute or chronic local or systemic osteomyelitis;
✕. Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);
What they're measuring
1
Changes of Costant Murley Score (CS)
Timeframe: From preoperative (baseline) to 24-month follow-up.