Affixus Natural Nail System Humeral Nail PMCF (NCT05019664) | Clinical Trial Compass
RecruitingNot Applicable
Affixus Natural Nail System Humeral Nail PMCF
United States, Belgium, Spain100 participantsStarted 2022-08-29
Plain-language summary
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …