Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion

NCT04679896 | Completed FDA Device

• 1 other identifier: MAG-920-059
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery. In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.

Conditions

Degenerative Disc Disease; Spine Fusion

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 (7)

• Radiographic Fusion by Plain Radiographs

  Week 2, Week 6, Month 3

• Posterolateral lumbar fusion assessed by CT-scan

  Month 6

• Interbody lumbar fusion assessed by plain radiographs

  Week 2, Week 6, Month 3, Month 6, Month 12

• Functional Outcome by Oswestry Disability Index

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

• General, back and Leg Pain by Visual Analog Pain Scale

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

Other Outcomes (8)

• 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 Putty

EXPERIMENTAL

MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side.

Device: MagnetOs Putty

Local autograft

OTHER

Device: MagnetOs Putty

Interventions

MagnetOs Putty DEVICE

Procedure: Instrumented posterolateral spine fusion

Local autograft; MagnetOs Putty

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 Investigational Review Board (IRB) approved informed consent.
• Male or female patient ≥ 18 years old.
• Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2 - S1).
• Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.

You may not qualify if:

• Requires \> three-level fusion or expected to need secondary intervention within one year following surgery.
• 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 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.
• Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
• Receiving treatment with medication interfering with calcium metabolism.
• Women who are or intend to become pregnant within the next 12 months.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Orthopaedic Institute of Western Kentucky: collaborator
• Simplified Clinical Data Systems, LLC: collaborator

Study Sites (1)

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Pascal Longlade, MD

  Kuros BioSciences B.V.

  STUDY DIRECTOR

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: Parallel Assignment 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: August 13, 2021
• Primary Completion: August 2, 2023
• Study Completion: December 2, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)