Actively Recruiting
A Study to Assess the Safety and Performance of MagnetOs Easypack Putty vs Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion
Led by Kuros Biosurgery AG · Updated on 2026-03-20
60
Participants Needed
6
Research Sites
12 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
Researchers are evaluating the safety and performance of MagnetOs Easypack Putty, a synthetic bone graft extender, in patients undergoing spinal fusion surgery for degenerative disc disease or spinal trauma. This phase IV post-marketing study compares MagnetOs Easypack Putty used alone to Demineralized Bone Matrix or Fibers mixed with autograft bone. The study addresses spinal fusion outcomes in patients with segmental mechanical instability who require surgery at one or two spine levels. In this randomized study, 60 patients will undergo up to two-level instrumented posterolateral fusion surgery. Each patient will receive MagnetOs Easypack Putty on one side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other side. The bone graft materials will be applied according to the latest U.S. instructions. Follow-up visits occur at discharge, 2 weeks, 3 months, 6 months, and 12 months post-surgery. Radiographs will be taken at screening, discharge, 3, 6, and 12 months, while CT scans will be done at 6 and 12 months. Participants will be monitored through physical exams, pain and disability questionnaires, and imaging to assess spinal fusion success and functional outcomes. Researchers will analyze fusion rates primarily by CT scan at 12 months, with interim analysis at 6 months. Safety and effectiveness will be tracked throughout the study duration, which lasts up to one year after surgery.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosed with segmental mechanical spinal instability needing arthrodesis surgery
- Requires up to two-level instrumented posterolateral lumbar or thoraco-lumbar fusion (T11 - S1)
- Mechanical instability defined by angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension X-rays, decreased disc height > 2 mm, Grade II or more listhesis, TLICS ≥ 5, or 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 secondary intervention within one year post-surgery
- Prior posterolateral fusion or attempted fusion at involved levels
- Previous decompression at involved levels
- Women who are or plan to become pregnant within 12 months
- Conditions where bone grafting is not advisable or surgical site may face excessive impact
- Significant vascular impairment near graft site
- Severe metabolic or systemic bone disorders affecting healing
- Acute or chronic infections in the operated area
- No planned or possible intraoperative soft tissue coverage
- Receiving medications that interfere with calcium metabolism
- Degenerative disc disease related to tumors
- History or presence of active malignancy
- Known substance abuse, psychiatric disorder, or conditions impacting 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
Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay until discharge
Participants undergo up to two-level instrumented posterolateral lumbar/thoracolumbar fusion surgery with randomized application of MagnetOs Easypack Putty on one side and Demineralized Bone Matrix or Fibers mixed with autograft bone on the other side.
1 visit (in-person, surgery and discharge)
Duration - 12 months
Participants are followed up to assess recovery, pain, neurologic status, and functional outcomes after surgery with imaging and clinical assessments.
Follow-up visits at Week 2, Month 3, Month 6, and Month 12
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
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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