Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 2:23 AM
Study NCT ID:
NCT06371833
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRIMA EU Retrospective & Prospective
Sponsor:
Limacorporate S.p.a
Organization:
Study Overview
Official Title:
A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: