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Efficacy and Safety of SurgiFill™ on Spinal Fusion

NCT02466048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-07

No results posted yet for this study

Summary

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

Conditions

  • Spinal Fusion Acquired
  • Fusion of Spine (Disease)

Interventions

PROCEDURE

Spinal Fusion

Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to join two or more vertebrae. Supplementary bone tissue, from the patient (autograft), is used in conjunction with the body's natural bone growth (osteoblastic) processes to fuse the vertebrae. Either the right or left side of one patient will be selected for the study group, and the other, for the control group, through randomization. In the study group site, SurgiFill™ and the autogenous bone mixture shall be transplanted, whereas in the control group site, only the autogenous bone shall be transplanted. The autogenous bones are from iliac part.

DEVICE

SurgiFill™

SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.

Sponsors & Collaborators

  • Sewon Cellontech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Young Hoon Kim, MD · The Catholic Univ. of Korea, Seoul St. Mary's Hospital

  • Young Yul Kim, MD · The Catholic Univ. of Korea, Daejeon St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-02-29
Completion
2016-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466048 on ClinicalTrials.gov