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Can a new shoulder implant restore Pain-Free movement?

NCT ID NCT06371833

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study follows 60 adults who receive a total shoulder replacement using the PRIMA humeral stem, either in an anatomic or reverse configuration. The goal is to measure changes in shoulder function, pain, and quality of life over 24 months, as well as how well the implant holds up and any complications. By tracking these outcomes, researchers hope to assess the short-term performance and safety of this implant in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRIMA humeral stem (a shoulder replacement implant used in anatomic or reverse configuration)
What this could lead to
If successful, this could confirm the PRIMA stem as a reliable option for shoulder replacement, potentially improving pain relief and arm function for people with severe shoulder arthritis or injury.
What could go wrong
This is a short-term study with only 60 participants, so results may not reflect long-term implant durability or apply to all patients. As with any surgery, risks include infection, implant loosening, or complications that could affect outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old; 2. Full skeletal maturity; 3. Life expectancy over 24 months; 4. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle; 5. 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; 6. 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; 7. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities. Exclusion Criteria: 1. Patients who lack capacity to be able to provide informed consent to participate in the study. 2. Local or systemic general infection; 3. Septicaemia; 4. Persistent acute or chronic local or systemic osteomyelitis; 5. Confirmed neurologic lesion compromising shoulder joint function; 6. Deltoid muscle insufficiency; 7. 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); 8. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course; 9. Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant; 10. Proximal humerus fracture sequelae with inadequate bone stock; 11. Vascular or nerve diseases affecting the concerned limb; 12. Metabolic disorders which may impair fixation and stability of the implant; 13. Any concomitant disease that might affect the implanted prosthesis; 14. Metal hypersensitivity to implant materials (CoCrMo); 15. Patient with significant renal impairment; 16. Lower mobility issues that may affect the study evaluation; 17. 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; 18. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant; 19. Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

    RECRUITING

    Cattolica, Rimini, 47841, Italy

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