RecruitingNot ApplicableNCT04679844

Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)


Sponsor

Kuros Biosurgery AG

Enrollment

60 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a bone graft substitute called MagnetOs Easypack Putty for use in spinal fusion surgery in the lower back. Spinal fusion joins two or more vertebrae together to stabilize the spine, and bone grafting material helps the bones grow together. This research compares MagnetOs Easypack Putty as a standalone graft material against a mix of demineralized bone matrix or fibers with the patient's own bone (autograft). You may be eligible if: - You are at least 18 years old - You have spinal instability requiring fusion surgery at one or two levels in the lower thoracic or lumbar spine (T11 to S1) - You have failed at least 3 months of conservative treatment (unless the instability is due to acute trauma) - The instability meets defined radiographic criteria (e.g., listhesis, collapsed disc height, or specific injury scores) You may NOT be eligible if: - You need more than a two-level fusion or are expected to need another surgery within a year - You have had previous fusion or decompression at the same levels - You are pregnant or planning to become pregnant within 12 months - You have significant metabolic bone disease (e.g., osteogenesis imperfecta, stage 4+ kidney disease, Paget's disease) - You have active infection, malignancy, or a history of cancer - You are involved in active spinal litigation Talk to your spine surgeon about whether your specific instability pattern and medical history make you a candidate for this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetOs Easypack Putty

MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.

DEVICEDemineralized Bone Matrix or Fibers mixed with local autograft bone

Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.


Locations(6)

The Regents of the University of California- Irvine Campus

Irvine, California, United States

Corewell Health

Grand Rapids, Michigan, United States

The Washington University

St Louis, Missouri, United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

University of Washington

Seattle, Washington, United States

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NCT04679844


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