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Recruiting NCT06371833

PRIMA EU Retrospective & Prospective

— Observational Arthroplasty Replacement Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shoulder Arthroplasy with PRIMA humeral stem.
Who it may be relevant to
Registry conditions: Arthroplasty, Replacement, Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty

Overview

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.

Interventions

  • Device Shoulder Arthroplasy with PRIMA humeral stem
    Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)

Primary outcome measures

  • Changes of Costant Murley Score (CS) [Time frame: From preoperative (baseline) to 24-month follow-up.]
Secondary outcome measures (5)
  • Changes in the American Shoudler and Elbow Surgeons (ASES) score [Time frame: From preoperative (baseline) to 24-month follow-up.]
  • Changes in Range of Motion measures [Time frame: From preoperative (baseline) to 24-month follow-up.]
  • Radiographic stability of the humeral component [Time frame: From immediate postoperative (baseline) to 24-months follow-up]
  • Survival rate (Kaplan-Meier estimate) [Time frame: From immediate post-operative to 24-months follow-up.]
  • Incidence, type and severity of Adverse Events and Adverse Device Effects [Time frame: From surgery to 24-months follow-up.]

Eligibility criteria

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:

  • non-inflammatory degenerative joint disease (i.e., osteoarthritis);
  • inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
  • avascular necrosis of the humeral head;
  • cuff tear arthropathy (CTA Heads only);

For Reverse configuration:

  • rotator cuff tear arthropathy;
  • osteoarthritiswith rotator cuff tear;
  • rheumatoid arthritis with rotator cuff tear;
  • massive irreparable rotator cuff tear;
  • 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;
  • Confirmed neurologic lesion compromising shoulder joint function;
  • Deltoid muscle insufficiency;
  • 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);
  • Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;
  • Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;
  • Proximal humerus fracture sequelae with inadequate bone stock;
  • Vascular or nerve diseases affecting the concerned limb;
  • Metabolic disorders which may impair fixation and stability of the implant;
  • Any concomitant disease that might affect the implanted prosthesis;
  • Metal hypersensitivity to implant materials (CoCrMo);
  • Patient with significant renal impairment;
  • Lower mobility issues that may affect the study evaluation;
  • Unwillingness or inability (due to physical or mental issues) 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;
  • Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;
  • Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy — Cattolica

Identifiers

NCT: NCT06371833 · S-52

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗