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

NCT04679844 | Recruiting FDA Device

• 1 other identifier: MAG-920-023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Spine Fusion; Degenerative Disc Disease; Back Pain

Keywords

Degenerative Disc Disease; Spine Fusion

Outcome Measures

Primary Outcomes (1)

• Radiographic Fusion by CT Scan

  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.

  Month 12

Secondary Outcomes (6)

• Radiographic Fusion by Plain Radiographs

  Month 6, Month 12

• Radiographic Fusion by CT Scan

  Month 6

• Functional Outcome by Oswestry Disability Index Questionnaire

  Screening, Week 2, Month 3, 6, and 12

• Back and Leg Pain by Visual Analog Pain Scale Questionnaire

  Screening, Week 2, Month 3, 6, and 12

• Neurologic Status by Physical Exam

  Screening, Week 2, Month 3, 6, and 12

Other Outcomes (7)

• Safety Endpoint - number of patients with Adverse Events

  12 Months

• Safety Endpoint - number of patients with Serious Adverse Events

  12 Months

• Safety Endpoint - number of patients with Adverse Device Effects

  12 Months

Study Arms (2)

MagnetOs Easypack Putty

EXPERIMENTAL

Interventions * Procedure: Instrumented posterolateral spine fusion * Device; MagnetOs Easypack Putty

Device: MagnetOs Easypack Putty

Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone

ACTIVE COMPARATOR

Interventions * Procedure: Instrumented posterolateral spine fusion * Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone

Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone

Interventions

MagnetOs Easypack Putty DEVICE

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

MagnetOs Easypack Putty

Demineralized Bone Matrix or Fibers mixed with local autograft bone DEVICE

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.

Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:
• instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
• decreased disc height by \> 2 mm, but dependent upon the spinal level
• Grade II or more listhesis
• TLICS equal or greater than 5
• Unstable burst fracture

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Simplified Clinical Data Systems, LLC: collaborator
• Kuros BioSciences B.V.: collaborator

Study Sites (6)

The Regents of the University of California- Irvine Campus

Irvine, California, 92697, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

The Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cesar Silva, MD

  Kuros BioSciences B.V.

  STUDY DIRECTOR

Central Study Contacts

Cesar Silva, MD

CONTACT

9702156793; cesar.silva@kurosbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient control. Each patient serves as their own control.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 22, 2020
• Study Start: December 6, 2024
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)