Evaluation of the safety and initial performance of the REPAIR Bone Putty in the treatment of patients with tibia fractures

Not Applicable

• Conditions: Musculoskeletal Diseases; Open tibia fractures

• Registration Number: PACTR201510001305535
• Lead Sponsor: Carmell Therapeutics Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fracture healing;Safety

Secondary Outcome Measures

Name	Time	Method
Wound assessment;Swelling;Tenderness;Neurovascular status;Infection;Weight Bearing