Actively Recruiting
PRIMA EU Retrospective & Prospective
Led by Limacorporate S.p.a · Updated on 2025-02-05
60
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PRIMA EU Retrospective & Prospective
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Full skeletal maturity
- Life expectancy over 24 months
- Shoulder joint anatomically and structurally suited for the implant with functional deltoid muscle
- Diagnosis of at least one of the following for anatomic configuration: non-inflammatory degenerative joint disease, inflammatory arthritis including rheumatoid arthritis, avascular necrosis of humeral head, cuff tear arthropathy
- Diagnosis of at least one of the following for reverse configuration: rotator cuff tear arthropathy, osteoarthritis with rotator cuff tear, rheumatoid arthritis with rotator cuff tear, massive irreparable rotator cuff tear
- Ability to understand study conditions and comply with rehabilitation and follow-up visits
- Signed informed consent approved by Ethics Committee
You will not qualify if you...
- Inability to provide informed consent
- Local or systemic infection
- Septicaemia
- Persistent acute or chronic osteomyelitis
- Neurologic lesion affecting shoulder function
- Deltoid muscle insufficiency
- Poor bone stock compromising implant stability
- Malignant cancer with life expectancy less than 2 years or affecting postoperative course
- Serious muscular, neurological, or vascular diseases compromising implant stability
- Proximal humerus fracture sequelae with inadequate bone stock
- Vascular or nerve diseases affecting the limb
- Metabolic disorders impairing implant fixation
- Any disease affecting the implanted prosthesis
- Metal hypersensitivity to implant materials (CoCrMo)
- Significant renal impairment
- Mobility issues affecting study evaluation
- Unwilling or unable to comply with rehabilitation or follow-up
- Psychiatric illness preventing study comprehension
- Women who are pregnant, nursing, or planning pregnancy
- Any clinically significant pathology affecting study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy
Cattolica, Rimini, Italy, 47841
Actively Recruiting
Research Team
C
Camilla Vianello
CONTACT
F
Francesca Citossi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here