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
This trial does not accept healthy volunteersQualifiers
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 population
The eligible study population consists of 60 adult patients requiring a primary Total Shoulder Arthroplasty (TSA) or Reverse Shoulder Arthroplasty (RSA). The decision to use PRIMA humeral stem has been taken by the Investigator prior to, and independently from, the decision to include the subject in the study.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Shoulder Arthroplasy with PRIMA humeral stem
DeviceData collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Adult patients requiring a primary TSA or RSA1 intervention
Trial outcomes
Primary outcomes
1
Changes of Costant Murley Score (CS)
The primary endpoint is to assess the change of Constant Murley Score (CS). Constant score (CS) is a clinical method of shoulder functional assessment that allows individual-parameter assessments to be combined with an overall 100-point scoring system. The final result is graded, with the normalized 100-point shoulder score, as excellent (85 to 100 points), good (71 to 84 points), fair (56-70), poor (0-55). The weighted Constant score is calculated as a percentage of norm
Time frame
From preoperative (baseline) to 24-month follow-up.Secondary outcomes
1
Changes in the American Shoudler and Elbow Surgeons (ASES) score
American Shoulder and Elbow Surgeons (ASES) score contains a patient self-report section and a section used by medical professionals to record physical examination findings to assess patients with shoulder pathologies. It is a patient self-evaluation questionnaire that takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points \[with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition\].
Time frame
From preoperative (baseline) to 24-month follow-up.2
Changes in Range of Motion measures
Range of active movements and passive movements, where available, are recorded for: * Forward elevation (passive and active); * External rotation with arm at the side (passive and active); * External rotation in 90° of abduction (passive and active); * Internal rotation (passive and active).
Time frame
From preoperative (baseline) to 24-month follow-up.3
Radiographic stability of the humeral component
All radiographs performed during the clinical study fall within site's standard of care. Views collected may include antero-posterior (AP) and axillary or scapula y view. In case CT scans, sonography, MRI are performed at specific time-points, they can be made available for collection and evaluation. Imaging are collected to evaluate the radiographic performance of the device.
Time frame
From immediate postoperative (baseline) to 24-months follow-up4
Survival rate (Kaplan-Meier estimate)
The Kaplan-Meier method is used to estimate the survivorship of the implant. Here, point estimates, 95% confidence bands and survival curve are provided. In case PRIMA humeral stem is revised for any reason, the patient will be followed up to the last follow up to evaluate the survival of the remaining component.
Time frame
From immediate post-operative to 24-months follow-up.Sponsors and contacts
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Source ClinicalTrials.gov