ArthroplastyNCT06371833
PRIMA EU Retrospective & Prospective
An observational study of Arthroplasty and Replacement, run by Limacorporate S.p.a at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- Shoulder Arthroplasy with PRIMA humeral stem
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2024to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy
Cattolica, Rimini, 47841
Paolo Paladini
About this study
Official title: A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
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
- Being tested
- Shoulder Arthroplasy with PRIMA humeral stem
- Keywords
- TSA, RSA, Shoulder replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Arthroplasy with PRIMA humeral stemDevice
Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Shoulder Arthroplasy with PRIMA humeral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From preoperative (baseline) to 24-month follow-up.
Secondary outcomes (5)
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].
Measured: 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:
- 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery to 24-months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start25 Oct 2024
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Castagna, Principal investigator, Humanitas Rozzano, ItalyPaolo Paladini, Principal investigator, Unit of Shoulder Surgery Romagna/ Cervesi Hospital, ItalyJörn Kircher, Principal investigator, ATOS Klinik Fleetinsel Hamburg, GermanyAmar Malhas, Principal investigator, Royal Berkshire NHS Trust, UKFernando Marco Martinez, Principal investigator, Hospital Clinico San Carlos, SpainIain Packham, Principal investigator, North Bristol NHS Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371833
- Sponsor's protocol ID
- S-52
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06371833
- Acronym / sponsor ID
- S-52
- Conditions
- Arthroplasty, Replacement, Shoulder
- Keywords
- TSA, RSA, Shoulder replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients requiring a primary TSA or RSA | – | Device: Shoulder Arthroplasy with PRIMA humeral stemDevice: PRIMA humeral stem in anatomic or reverse configuration Shoulder arthroplasty according to the instruction for use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder Arthroplasy with PRIMA humeral stemData collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration) | Device | Adult patients requiring a primary TSA or RSA |
Primary outcome
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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Castagna principal investigator
Humanitas Rozzano, Italy
Paolo Paladini principal investigator
Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy
Jörn Kircher principal investigator
ATOS Klinik Fleetinsel Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Replacement, run by Limacorporate S.p.a at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Vianello (+390432945357, camilla.vianello@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Costant Murley Score (CS) (time frame: From preoperative (baseline) to 24-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.