A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthroplasty
- Sponsor
- Limacorporate S.p.a
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes of Costant Murley Score (CS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
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);
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;
Outcomes
Primary Outcomes
Changes of Costant Murley Score (CS)
Time Frame: From preoperative (baseline) to 24-month follow-up.
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
Secondary Outcomes
- Changes in the American Shoudler and Elbow Surgeons (ASES) score(From preoperative (baseline) to 24-month follow-up.)
- Changes in Range of Motion measures(From preoperative (baseline) to 24-month follow-up.)
- Radiographic stability of the humeral component(From immediate postoperative (baseline) to 24-months follow-up)
- Survival rate (Kaplan-Meier estimate)(From immediate post-operative to 24-months follow-up.)
- Incidence, type and severity of Adverse Events and Adverse Device Effects(From surgery to 24-months follow-up.)