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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients requiring a primary TSA or RSA | Device: PRIMA humeral stem in anatomic or reverse configuration Shoulder arthroplasty according to the instruction for use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder Arthroplasy with PRIMA humeral stem | Device | Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From preoperative (baseline) to 24-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. |
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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:
For Anatomic configuration:
For Reverse configuration:
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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Vianello | Contact | +390432945357 | camilla.vianello@limacorporate.com | |
| Francesca Citossi | Contact | +390432945357 | francesca.citossi@limacorporate.com |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Castagna | Humanitas Rozzano, Italy | Principal Investigator |
| Paolo Paladini | Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy | Recruiting | Cattolica | Rimini | 47841 | Italy |
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| From preoperative (baseline) to 24-month follow-up. |
| Changes in Range of Motion measures | Range of active movements and passive movements, where available, are recorded for:
| From preoperative (baseline) to 24-month follow-up. |
| 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. | From immediate postoperative (baseline) to 24-months follow-up |
| 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. | From immediate post-operative to 24-months follow-up. |
| Incidence, type and severity of Adverse Events and Adverse Device Effects | Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up. | From surgery to 24-months follow-up. |
| Jörn Kircher |
| ATOS Klinik Fleetinsel Hamburg, Germany |
| Principal Investigator |
| Amar Malhas | Royal Berkshire NHS Trust, UK | Principal Investigator |
| Fernando Marco Martinez | Hospital Clinico San Carlos, Spain | Principal Investigator |
| Iain Packham | North Bristol NHS Trust, UK | Principal Investigator |