A Non ?Randomized, prospective Post Market Clinical Follow ?up study to evaluate theSafety and Performance of Radius system intended for Radius fracture fixation.

Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•? Subject is willing and able to give written informed consent for participation in the study.
•? Male or Female, aged 18 years or above, skeletally mature patient.
•? Subject is willing and able to complete equired study visits or assessments.
•? Participant has confirmed diagnosis as per the indications

•? Subjects with a disease entity or condition that totally
•precludes the possibility of bony fusion such as known active
•cancer, etc.
•? Subject having any neuromuscular disorder, which would
•create an unacceptable risk of fixation failure or
•complications in postoperative care.
•? Subjects unwilling to sign the Informed Consent document.
•? Subjects with substance abuse/alcohol issues.
•? Subjects who are incarcerated or have pending incarceration.
•? Female participant who is pregnant or planning pregnancy
•during the course of the study.
•? Subject having infection local to the operative site.
•? Any uncontrolled systemic disease that, in the opinion of the
•Investigator, would preclude participation in the study (e.g.,unstable medical status including uncontrolled elevated blood
•pressure, cardiovascular disease, and glycemic control) or put
•the subject at risk due to study treatment or procedures.
•? Subject with rapid joint disease, bone absorption, osteopenia, and/or osteoporosis.
•? Subject having suspected or documented metal allergy or intolerance.

发起方

Auxein Medical Pvt Ltd