PACTR201510001305535
Completed
未知
A Randomized Controlled Clinical Study to Determine the Safety and Effectiveness of the REPAIR Bone Putty in Tibia Fractures
Carmell Therapeutics Corp.0 sites30 target enrollmentOctober 13, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Musculoskeletal Diseases
- Sponsor
- Carmell Therapeutics Corp.
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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