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.

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.)

Bone formation completion date

Timeframe: at time of bone formation completion

NCT IDNCT07518836

SponsorCellontech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08