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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent. 2. Male or female patient ≥ 18 years old. 3. Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2

- S1).

4. 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.

Exclusion Criteria:

1. Requires > three-level fusion or expected to need secondary intervention within one year following surgery. 2. To treat conditions in which general bone grafting is not advisable. 3. 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). 4. In case of significant vascular impairment proximal to the graft site. 5. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing. 6. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). 7. When intraoperative soft tissue coverage is not planned or possible. 8. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space. 9. Receiving treatment with medication interfering with calcium metabolism. 10. Women who are or intend to become pregnant within the next 12 months.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04679896
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kuros Biosurgery AG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pascal Longlade, MD
Principal Investigator Affiliation	Kuros BioSciences B.V.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease, Spine Fusion

Additional Details

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Day 0, Week 6, Month 3. CT scans will only be obtained at Month 6 and Month 12.

Arms & Interventions

Arms

Experimental: MagnetOs Putty

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.

Other: Local autograft

Interventions

Device: - MagnetOs Putty

Procedure: Instrumented posterolateral spine fusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Paducah, Kentucky

Status

Recruiting

Address

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

Site Contact

Brandon Strenge, MD

[email protected]

+31622210098

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