A Randomized Controlled Clinical Study to Determine the Safety and Effectiveness of the REPAIR Bone Putty in Tibia Fractures

Carmell Therapeutics Corp.0 个研究点目标入组 30 人开始时间: 2015年10月13日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Patients between the age of 18-75 inclusive;
•Patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and radiograms indicated for open fracture reduction and mechanical fixation;
•Definitive Wound Closure (DWC) within 14 days of initial injury;
•In bilateral open tibia fractures, only one fracture meeting all inclusion/exclusion criteria will be treated ¿ should both fractures meet the criteria, the selected fracture will be randomly chosen;
•¿Subject is willing to be available for post operative follow-up examinations;
•Willingness and ability to understand, participate and comply with the study requirements;
•Able to give consent personally and to sign the Consent Form;
•Females of non-childbearing potential or who have a negative pregnancy test with 72 hours.

•Type IIIc open fracture according to the Gustilo-Anderson classification;
•Tibial defects requiring bone grafting (e.g., large segmental defects);
•Duration from trauma to surgery longer than 14 days;
•Concomitant acute bone injuries and/or major skin or other injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process;
•Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years;
•Subject is participating in another investigational trial that has not completed the primary study endpoint phase;
•Taking medication known to potentially interfere with bone/soft tissue healing (e.g., long term use of corticosteroids but not intended to exclude inhalation medication for asthma);
•Active infection at the operative site or a systemic infection;
•Any psychosocial disorders that could impact the follow up assessments or informed consent process.

发起方

Carmell Therapeutics Corp.