Musculoskeletal Diseases Open tibia fractures
Conditions
Interventions
REPAIR Bone Putty
Standard of care
Sponsors
Carmell Therapeutics Corp.
3 Degree Clinical Research & Consulting
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing;Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound assessment;Swelling;Tenderness;Neurovascular status;Infection;Weight Bearing | — |
Countries
South Africa
Contacts
Public ContactHein Botha
3 Degree Clinical Research & Consulting
Outcome results
None listed