NCT04679844 Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
| NCT ID | NCT04679844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kuros Biosurgery AG |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2027-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-06 with a primary completion date of 2027-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
Eligibility Criteria
Inclusion Criteria: * 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: 1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs), 2. decreased disc height by \> 2 mm, but dependent upon the spinal level 3. Grade II or more listhesis 4. TLICS equal or greater than 5 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 Criteria: * 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.
Contact & Investigator
Cesar Silva, MD
STUDY DIRECTOR
Kuros BioSciences B.V.
Frequently Asked Questions
Who can join the NCT04679844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04679844 currently recruiting?
Yes, NCT04679844 is actively recruiting participants. Contact the research team at cesar.silva@kurosbio.com for enrollment information.
Where is the NCT04679844 trial being conducted?
This trial is being conducted at Irvine, United States, Grand Rapids, United States, St Louis, United States, Philadelphia, United States and 2 additional locations.
Who is sponsoring the NCT04679844 clinical trial?
NCT04679844 is sponsored by Kuros Biosurgery AG. The principal investigator is Cesar Silva, MD at Kuros BioSciences B.V.. The trial plans to enroll 60 participants.