Bone Fracture, Femur Fracture, Tibia Fracture
Conditions
Keywords
Collagen, bone graft, Femoral and Tibial Fracture
Brief summary
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
Detailed description
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™.
Interventions
PROCEDUREfemur or tibia fracture
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.
DEVICESurgiFill™
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type.
Sponsors
Cellontech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Patients with closed fracture out of the joint from below the trochanter of the femur up to the distal femur or in the tibia 2. Patients who agreed to participate in the study and signed the informed consent form
Exclusion criteria
1. Patients or their family members with a history of an or an ongoing autoimmune disease 2. Patients with a history of anaphylactic response 3. Patients with hypersensitivity to grafting materials 4. Patients with hypersensitivity to porcine protein 5. Patients with osteomyelitis in the surgery area 6. Patients who are pregnant, breastfeeding, or planning to become pregnant 7. Patients with other tumors or a non-curable disease 8. Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.) 9. Patients with diabetes (Those who maintain a normal blood sugar level and did not develop complications may receive the SurgiFill™ injection based on the investigator's judgment, but the doctor's confirmation is required.) 10. Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents 11. Patients who have been undergoing adrenocortical hormone therapy (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.) 12. Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment. Hypertension patients are allowed.) 13. Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.) 14. Patients with chronic renal failure or an endocrine system disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.) 15. Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment 16. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone formation completion date | at time of bone formation completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Callus Formation Score change | post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter. | 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. |
| Detailed callus formation date | at the periods of the first, second, third, and fourth callus formation and endosteal healing. | The investigators and radiographers will record the periods of the first, second, third, and fourth callus formation and endosteal healing. |
| Date of full weight bearing | at time of full weight bearing available | The investigators and radiographers will record the date when the patient can already bear his or her full weight on the treated leg. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYoung Wook Yim, MD
The Catholic University of Korea
PRINCIPAL_INVESTIGATORJae Kwan Kong, MD
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
PRINCIPAL_INVESTIGATORJun Bum Kim, MD
Daejeon Sun Hospital
Outcome results
None listed