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

Completed · Not applicable

Conditions studied: Degenerative Disc Disease, Spine Fusion

In brief

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.

Key facts

Study ID

NCT04679896

Run by

Kuros Biosurgery AG

People needed

30

Starts

2021-08-13

Expected to finish

2023-12-02

Last updated by the study team

2024-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States

Full record on ClinicalTrials.gov

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