Status:
RECRUITING
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Lead Sponsor:
Zimmer Biomet
Conditions:
Proximal Humerus Fracture
Posttraumatic Arthrosis After Humeral Head Fracture
Eligibility:
All Genders
18+ years
Brief Summary
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 sa...
Detailed Description
The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoul...
Eligibility Criteria
Inclusion
- Patients 18 years or older and skeletally mature
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
- Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
- Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
- Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
- Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
- Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
- Posttraumatic necrosis of the humeral head
- Posttraumatic arthrosis after humeral head fracture
Exclusion
- Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
- The patient is known to be pregnant or breastfeeding
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Patients with plans to relocate during the study follow-up period
- Signs of infection
- Extensive stiffening of the shoulder joint without pain
Key Trial Info
Start Date :
July 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 21 2034
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05351112
Start Date
July 7 2022
End Date
January 21 2034
Last Update
August 17 2025
Active Locations (1)
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1
Salamenca University Hospital
Salamanca, Spain, 37007