Actively Recruiting
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Led by Zimmer Biomet · Updated on 2025-08-17
78
Participants Needed
1
Research Sites
602 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
CONDITIONS
Official Title
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older and skeletally mature
- Able to understand surgeon's explanations and willing to follow instructions
- Willing to participate in the follow-up program and gave consent
- Replacement of proximal humerus and glenoid surface during total, hemi, or fracture shoulder arthroplasty for:
- Complex 3- and 4-part proximal humerus fractures with head fragment subluxation
- Complex 3- and 4-part fractures with loosening of spongiosa in head fragment
- Complex 3- and 4-part fractures with additional cross split of head fragment
- Fracture instability after osteosynthesis of 3- and 4-part proximal humerus fractures
- Posttraumatic necrosis of the humeral head
- Posttraumatic arthrosis after humeral head fracture
You will not qualify if you...
- Unwilling or unable to give consent or comply with follow-up visits
- Known pregnancy or breastfeeding
- Conditions placing patient at undue risk or interfering with study
- Vulnerable subjects (prisoners, mentally incompetent, known substance abusers, anticipated non-compliant)
- Plans to relocate during follow-up period
- Signs of infection
- Extensive stiffening of shoulder joint without pain
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Salamenca University Hospital
Salamanca, Spain, 37007
Actively Recruiting
Research Team
J
Julie Nicoux
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
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