Status:
RECRUITING
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Lead Sponsor:
Kuros Biosurgery AG
Collaborating Sponsors:
Simplified Clinical Data Systems, LLC
Kuros BioSciences B.V.
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 Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients w...
Detailed Description
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be...
Eligibility Criteria
Inclusion
- 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
- 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 (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.
Exclusion
- 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.
- Has participated in an investigational study within 30 days prior to surgery for study devices.
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04679844
Start Date
December 6 2024
End Date
August 30 2027
Last Update
November 20 2025
Active Locations (4)
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1
The Washington University
St Louis, Missouri, United States, 63130
2
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
3
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37209
4
University of Washington
Seattle, Washington, United States, 98104