This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
This study is an open-trial study. The purpose and procedure of study will be explained to the subjects, and they will voluntarily decide to participate in it. Their eligibility to participate in the study will be checked, and the subjects will be randomized into the study group or the control group (via stratified randomization) based on the severity of their disease and the surgery method. The study group will receive treatment for fracture (fixation) and SurgiFill™ injection, and the control group will receive only fracture treatment. For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening. At each visit, the subjects will undergo an examination with doctors and a X-ray procedure to evaluate the safety and efficacy of SurgiFill™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
60
For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed.
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type.
Daejeon Sun Hospital
Daejeon, Daejeon, South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
Bone formation completion date
The investigators will evaluate the bone formation and record the date of completion of the bone formation. The criteria for the bone formation completion are when the third callus has formed completely and when the patient no longer feels pain when he or she bears his or her full weight on his or her treated leg.
Time frame: at time of bone formation completion
Callus Formation Score change
From the results of the X-rays at six, 10, 13, 16, and 22 weeks and every eight weeks thereafter, the investigators and radiographers will confirm if there is a new callus on the X-ray results; and if there is, they will record the scores separately (not together) from 0-2 and add them up.
Time frame: post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter.
Detailed callus formation date
The investigators and radiographers will record the periods of the first, second, third, and fourth callus formation and endosteal healing.
Time frame: at the periods of the first, second, third, and fourth callus formation and endosteal healing.
Date of full weight bearing
The investigators and radiographers will record the date when the patient can already bear his or her full weight on the treated leg.
Time frame: at time of full weight bearing available
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