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MagnetOs™ Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

NCT03625544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-11

No results posted yet for this study

Summary

The purpose of this study is to demonstrate non-inferiority of MagnetOs™ Granules as an alternative to autologous bone graft in adult patients undergoing an instrumented posterolateral fusion of the thoracolumbar, lumbar or lumbosacral spine, in terms of efficacy and safety. After instrumentation and based on randomization, one side of the spine will be grafted with MagnetOs™ Granules and the other side with autologous bone graft. Thereby, each patient serves as its own control.

Conditions

  • Spinal Fusion

Interventions

PROCEDURE

Instrumented posterolateral spinal fusion

Instrumented posterolateral spinal fusion, with or without an additional interbody device

DEVICE

MagnetOs™ Granules

8-10cc of MagnetOs™ Granules per spinal level at the randomized allocation side of the spine (left or right)

PROCEDURE

Autologous bone graft

8-10cc autologous bone graft per spinal level at the control side of the spine (left or right). This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft.

Sponsors & Collaborators

  • Kuros BioSciences B.V.

    collaborator INDUSTRY

  • M.C. Kruyt, MD, PhD

    lead OTHER

Principal Investigators

  • Moyo Kruyt, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-04
Primary Completion
2023-10-30
Completion
2024-10-07

Countries

  • Netherlands

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 NCT03625544 on ClinicalTrials.gov