Actively Recruiting
A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
Led by Limacorporate S.p.a · Updated on 2025-02-05
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical, radiographic, and patient-reported outcomes of total shoulder replacement using the PRIMA humeral stem in either anatomic or reverse configurations. The study focuses on assessing the short-term performance of the implant up to 24 months after surgery, including implant survivorship and the occurrence of complications. Adult patients requiring primary total shoulder arthroplasty or reverse shoulder arthroplasty are included. Participants receive a shoulder arthroplasty procedure with the PRIMA humeral stem according to the manufacturer's instructions. The device is implanted in either an anatomic or reverse configuration based on patient indication. The study is observational, collecting data from patients who have undergone this procedure to monitor outcomes over time. Throughout the study, participants will have their clinical status assessed using scores like the Constant Murley Score and the American Shoulder and Elbow Surgeons score, as well as measurements of shoulder range of motion. Radiographic evaluations will monitor the stability of the humeral component. Researchers will also track adverse events and implant survival for up to 24 months post-surgery. Follow-up visits and evaluations are scheduled to gather comprehensive data on the implant's performance and patient recovery.
CONDITIONS
Brief 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 suitable for the implant with functional deltoid muscle
- Indications for anatomic configuration include osteoarthritis, inflammatory arthritis, avascular necrosis, or cuff tear arthropathy
- Indications for reverse configuration include rotator cuff tear arthropathy, osteoarthritis with rotator cuff tear, rheumatoid arthritis with rotator cuff tear, or massive irreparable rotator cuff tear
- Ability to understand study conditions and comply with rehabilitation and follow-up visits
- Signed informed consent form approved by Ethics Committee
You will not qualify if you...
- Unable to provide informed consent
- Local or systemic infection
- Septicaemia
- Acute or chronic osteomyelitis
- Neurologic lesion impairing shoulder function
- Deltoid muscle insufficiency
- Poor bone quality compromising implant stability
- Malignant cancer with life expectancy less than 2 years or affecting postoperative course
- Serious muscular, neurological, or vascular diseases affecting implant stability
- Proximal humerus fracture sequelae with inadequate bone stock
- Vascular or nerve diseases affecting the limb
- Metabolic disorders impairing implant fixation
- Any condition affecting the implanted prosthesis
- Metal allergy to implant materials
- Significant kidney impairment
- Reduced mobility affecting study evaluation
- Inability or unwillingness to comply with rehabilitation or follow-up or psychiatric illness preventing study understanding
- Women who are pregnant, nursing, or planning pregnancy
- Any significant pathology that may affect study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo total shoulder arthroplasty with the PRIMA humeral stem according to standard surgical procedures.
1 surgery visit (in-person)
Duration - 24 months
Participants are followed to assess clinical and radiological outcomes including function, range of motion, implant stability, and adverse events.
Regular follow-up visits over 24 months
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
F
Francesca Citossi
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
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