Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture (NCT07518836) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture
Stopped: The study was terminated early due to company reasons.
South Korea60 participantsStarted 2013-02
Plain-language summary
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.)