CompletedNot Applicable

Efficacy and Safety of SurgiFill™ on Spinal Fusion

South Korea20 participantsStarted 2013-08

Plain-language summary

This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.

Age range20 Years

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 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 pig 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.)

Volume change of bony fusion mass in the CT

Timeframe: 1week, 6month, and 12month

NCT IDNCT02466048

SponsorCellontech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02