PRIMA EU Retrospective & Prospective

NCT06371833 | Recruiting

• 1 other identifier: S-52
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty; Replacement; Shoulder

Keywords

TSA; RSA; Shoulder replacement

Outcome Measures

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

  From preoperative (baseline) to 24-month follow-up.

Secondary Outcomes (5)

• 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.

Study Arms (1)

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.

Device: Shoulder Arthroplasy with PRIMA humeral stem

Interventions

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)

Adult patients requiring a primary TSA or RSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

Cattolica, Rimini, 47841, Italy

RECRUITING

Study Officials

• Alessandro Castagna

  Humanitas Rozzano, Italy

  PRINCIPAL INVESTIGATOR

• Paolo Paladini

  Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Camilla Vianello

CONTACT

+390432945357; camilla.vianello@limacorporate.com

Francesca Citossi

CONTACT

+390432945357; francesca.citossi@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 17, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

IT (1)