Upper arm fracture nail system put to the test in 100-patient study
NCT ID NCT05019664
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks how well a commercially available nail system works for fixing broken upper arm bones. 100 adults who need surgery for a humerus fracture will be followed for 12 months to see if the bone heals enough for normal activities. The goal is to confirm the device is safe and helps patients regain arm function.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive series of 100 subjects globally implanted with the Affixus Natural Nail System Humeral Nail for temporary fixation and stabilization of fractures or osteotomies of the humerus.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 18 years or older and skeletally mature. * Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing. * Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail. * Patient must be able and willing to complete the protocol required follow-up. * Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.) * 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. 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 the implant. * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions. * 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). * Patient known to be pregnant or breast feeding. * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). * Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study. * Not expected to survive the duration of the follow-up program.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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General Foundation of the University of Valladolid
Valladolid, Valladolid, 47002, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
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Kantonsspital Frauenfeld
Frauenfeld, Thurgau, 8501, Switzerland
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UZ Leuven - Traumatology Department
Leuven, 3000, Belgium
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
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