NCT07518836

Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture

A Clinical Trial to Investigate the Safety and Efficacy of SurgiFill™, a Bone Grafting Material, in Patients With Femur or Tibia Fracture.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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™.

Conditions

• Bone Fracture
• Tibia Fracture
• Femur Fracture

Interventions

Type	Name	Description
PROCEDURE	femur 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.
DEVICE	SurgiFill™	SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

3 sites across 1 country: South Korea