Last updated: April 5, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Affixus Natural Nail System
Clinical Study ID
NCT05019664
CMG2020-09T
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients 18 years or older and skeletally mature.
- Patient must have either a proximal humeral fracture or humeral shaft fracturerequiring surgical intervention and be eligible for fixation by intramedullarynailing.
- Patient has been or is scheduled to be treated with the Affixus Natural Nail SystemHumeral Nail.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must have a signed Institutional Review Board/Ethics Committee approvedinformed consent. (An Institutional Review Board/Ethics Committee is group that hasbeen formally designated to review and monitor medical research involving humansubjects.)
- Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study.
Exclusion
Exclusion Criteria:
- Distal fracture involving the olecranon fossa.
- Bone shaft having excessive bow or deformity.
- A medullary canal obliterated by a previous fracture or tumor.
- Active or previous infection.
- Skeletally immature patients.
- All concomitant diseases that can impair the functioning and the success of theimplant.
- Patients with mental or neurologic conditions who are unwilling or incapable of givingproper informed consent and following postoperative care instructions.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, a known alcohol or drug abuser,anticipated to be non-compliant).
- Patient known to be pregnant or breast feeding.
- Likely problems with maintaining follow-up program (e.g. patient with no fixedaddress, long distance, plans to move during course of study).
- Patients who have any condition that would in the judgment of the investigator placethe patient at undue risk or interfere with the study.
- Not expected to survive the duration of the follow-up program.
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Affixus Natural Nail System
Phase:
Study Start date:
August 29, 2022
Estimated Completion Date:
August 31, 2027
Study Description
Connect with a study center
UZ Leuven - Traumatology Department
Leuven, 3000
BelgiumActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Kantonsspital Frauenfeld
Frauenfeld, Thurgau 8501
SwitzerlandActive - Recruiting
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
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