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Post-Market Study of MagnetOs Easypack Putty for Spinal Fusion

This study is looking at how well MagnetOs Easypack Putty works in patients having spinal fusion surgery for conditions like degenerative disc disease (wear and tear of spinal discs) and back pain. MagnetOs Easypack Putty is a synthetic (man-made) material that helps bone grow. Researchers will compare it to another common material, Demineralized Bone Matrix or Fibers, mixed with your own bone. You could be eligible if you are at least 18 years old and need spinal fusion due to spinal instability. The main goal is to see if the spine has successfully fused (joined together) after 12 months, as seen on a CT scan. The study is currently unclear on its recruitment status and plans to enroll 60 patients.

Study design
This is an interventional study where 60 patients will be randomly assigned to receive MagnetOs Easypack Putty on one side of their spine and Demineralized Bone Matrix or Fibers with their own bone on the other side during surgery.
What's involved
You would have a screening period of up to 30 days, undergo spinal fusion surgery, and have follow-up visits at discharge, Week 2, Month 3, Month 6, and Month 12. X-rays and CT scans will also be performed at specific times.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment, with the primary outcome measured at Month 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04679844

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

Recruiting
NAAges 18+InterventionalTreatment
Kuros Biosurgery AG
~60 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:MagnetOs Easypack PuttyDemineralized Bone Matrix or Fibers mixed with local autograft bone

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Fusion by CT Scan
Measured over Month 12

Conditions

Degenerative Disc Disease
Spine Fusion
Back Pain

Explore related trials

Intervertebral Disc Degenerative DisorderSpinal Trauma

Where it's being run

6 sites across 6 states
California1
Michigan1
Missouri1
Pennsylvania1
Tennessee1
Washington1

Study leadership

  • Cesar Silva, MD · STUDY_DIRECTOR · Kuros BioSciences B.V.

Who to contact

Cesar Silva, MD
[email protected]
9702156793
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
Male or female patient ≥ 18 years old.
Patients with segmental mechanical spinal instability requiring arthrodesis surgery.

Exclusion

Requires \> two-level fusion or expected to need secondary intervention within one year following surgery.
Had prior PLF fusion or attempted PLF fusion at the involved levels.
Had previous decompression at the involved levels.
Women who are or intend to become pregnant within the next 12 months.
To treat conditions in which general bone grafting is not advisable.
In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).
In case of significant vascular impairment proximal to the graft site.
In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage \>4 renal disease or Paget's Disease) that affect bone or wound healing.
In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
When intraoperative soft tissue coverage is not planned or possible.
Receiving treatment with medication interfering with calcium metabolism.
Has degenerative disc disease (DDD) related to a benign or malignant tumor.
Has history or presence of active malignancy.
Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
Is involved in active litigation relating to his/her spinal condition.
Has participated in an investigational study within 30 days prior to surgery for study devices.

What this trial measures

  • Radiographic Fusion by CT ScanMonth 12

    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.