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

NCT07518836 | Terminated DMC

• 1 other identifier: 01SGF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Bone Fracture; Tibia Fracture; Femur Fracture

Keywords

Collagen; bone graft; Femoral and Tibial Fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  at time of bone formation completion

Secondary Outcomes (3)

• Callus Formation Score change

  post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter.

• Detailed callus formation date

  at 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

Study Arms (2)

SurgiFill™ on femur or tibia fracture

EXPERIMENTAL

The study group will receive treatment for fracture and SurgiFill™ injection.

Procedure: femur or tibia fracture; Device: SurgiFill™

Treatment on femur or tibia fracture

ACTIVE COMPARATOR

The control group will receive only fracture treatment.

Procedure: femur or tibia fracture

Interventions

femur or tibia fracture PROCEDURE

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.

Also known as: Treatment for fracture, open-reduction internal fixation

SurgiFill™ on femur or tibia fracture; Treatment on femur or tibia fracture

SurgiFill™ DEVICE

SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type.

SurgiFill™ on femur or tibia fracture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with closed fracture out of the joint from below the trochanter of the femur up to the distal femur or in the tibia
• Patients who agreed to participate in the study and signed the informed consent form

You may not qualify if:

• Patients or their family members with a history of an or an ongoing autoimmune disease
• Patients with a history of anaphylactic response
• Patients with hypersensitivity to grafting materials
• Patients with hypersensitivity to porcine protein
• Patients with osteomyelitis in the surgery area
• Patients who are pregnant, breastfeeding, or planning to become pregnant
• Patients with other tumors or a non-curable disease
• 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.)
• 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.)
• Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
• 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.)
• 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.)
• 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.)
• 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.)
• 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

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (3)

Daejeon Sun Hospital

Daejeon, Daejeon, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seoul, 137701, South Korea

Location

MeSH Terms

Conditions

Fractures, Bone; Tibial Fractures; Femoral Fractures

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Young Wook Yim, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Jae Kwan Kong, MD

  The Catholic University of Korea, Uijeongbu St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Jun Bum Kim, MD

  Daejeon Sun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: April 9, 2026
• Study Start: February 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 9, 2026

Record last verified: 2015-08

Locations

KR (3)