PRIMA EU Retrospective & Prospective
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Shoulder Arthroplasy with PRIMA humeral stem
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov