Can a new shoulder implant restore Pain-Free movement?
NCT ID NCT06371833
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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy
RECRUITINGCattolica, Rimini, 47841, Italy
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