Actively 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
Led by Kuros Biosurgery AG · Updated on 2026-03-20
60
Participants Needed
6
Research Sites
142 weeks
Total Duration
On this page
Sponsors
K
Kuros Biosurgery AG
Lead Sponsor
S
Simplified Clinical Data Systems, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Male or female patient 18 years or older
- Segmental mechanical spinal instability requiring arthrodesis surgery
- Instability caused by degenerative disc disease or traumatic spinal injury
- Scheduled for up to two-level instrumented posterolateral lumbar/thoracolumbar fusion (T11 - S1)
- Mechanical instability defined by one or more: angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs, decreased disc height > 2 mm, Grade II or more listhesis, TLICS ≥ 5, unstable burst fracture
- Failed conservative treatment for at least 3 months prior to enrollment if elective surgery
You will not qualify if you...
- Requires more than two-level fusion or expected need for secondary intervention within one year
- Prior posterolateral fusion or attempted fusion at involved levels
- Previous decompression at involved levels
- Pregnant or intending pregnancy within next 12 months
- Conditions where general bone grafting is not advisable
- Surgical site subjected to excessive impact or stresses beyond fixation hardware strength
- Significant vascular impairment near graft site
- Severe metabolic or systemic bone disorders affecting bone or wound healing
- Acute or chronic infections at operated area
- Intraoperative soft tissue coverage not planned or possible
- Treatment with medication interfering with calcium metabolism
- Degenerative disc disease related to benign or malignant tumor
- History or presence of active malignancy
- Known substance abuse, psychiatric disorder, or condition affecting healing or protocol compliance
- Involved in active litigation related to spinal condition
- Participation in investigational study within 30 days prior to surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Regents of the University of California- Irvine Campus
Irvine, California, United States, 92697
Actively Recruiting
2
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
3
The Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
4
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37209
Actively Recruiting
6
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
C
Cesar Silva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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