A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
The Washington University
RECRUITING
St Louis
Pennsylvania
Rothman Orthopaedic Institute
RECRUITING
Philadelphia
Tennessee
Tennessee Orthopaedic Alliance
RECRUITING
Nashville
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Katherine Sage, DO
Katherine.Sage@kurosbio.com
617 285 2489
Backup
Cesar Silva, MD
Cesar.silva@kurosbio.com
9702156793
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2027-08-30
Participants
Target number of participants: 60
Treatments
Experimental: MagnetOs Easypack Putty
Interventions~* Procedure: Instrumented posterolateral spine fusion~* Device; MagnetOs Easypack Putty
Active_comparator: Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone
Interventions~* Procedure: Instrumented posterolateral spine fusion~* Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone
Related Therapeutic Areas
Sponsors
Collaborators: Kuros BioSciences B.V., Simplified Clinical Data Systems, LLC
Leads: Kuros Biosurgery AG

This content was sourced from clinicaltrials.gov