Status:
COMPLETED
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Lead Sponsor:
Kuros Biosurgery AG
Collaborating Sponsors:
Orthopaedic Institute of Western Kentucky
Simplified Clinical Data Systems, LLC
Conditions:
Degenerative Disc Disease
Spine Fusion
Eligibility:
All Genders
18+ years
Phase:
NA
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/o...
Detailed Description
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 wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04679896
Start Date
August 13 2021
End Date
December 2 2023
Last Update
February 13 2024
Active Locations (1)
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1
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42001