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Bone Graft
MagnetOs Putty for Spinal Fusion (PROOF Trial)
N/A
Waitlist Available
Research Sponsored by Kuros Biosurgery AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Had prior PLF fusion or attempted PLF fusion at the involved levels.
Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, month 3, 6, and 12
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to assess the safety and effectiveness of MagnetOs Putty as a bone graft extender mixed with autograft in patients undergoing posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), or lumbar interbody fusion (LIF).
Who is the study for?
This trial is for adults over 18 with degenerative disc disease needing a two-level spinal fusion surgery, who have tried other treatments like physical therapy or medications for at least 3 months without success. It's not suitable for pregnant women, those with previous surgeries at the same spine levels, infections in the area, bone diseases affecting healing, or anyone involved in litigation related to their spinal condition.
What is being tested?
The study compares MagnetOs Putty—a synthetic bone graft extender—with Demineralized Bone Matrix mixed with autograft bone. Patients undergoing lumbar fusion surgery will receive these materials to see how well they help the spine heal and fuse compared to each other.
What are the potential side effects?
While specific side effects are not listed here, typical risks of using bone graft extenders include infection risk at the surgical site, inflammation around the area where it's applied, potential allergic reactions to materials used and complications related to improper spine fusion.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a previous spinal fusion surgery.
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I am having a procedure involving MagnetOs in my joint space.
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My surgery does not include or allow for soft tissue coverage.
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I have or had another type of cancer.
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I have had surgery to relieve pressure on my spine.
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My surgery area can't handle a lot of pressure or movement.
Select...
I do not have severe bone disorders like osteogenesis imperfecta or Paget's Disease.
Select...
I am on medication that affects how my body handles calcium.
Select...
I need a small spinal fusion surgery or might need another surgery within a year.
Select...
I have an infection in the area that was operated on.
Select...
My back pain is due to a tumor affecting my spinal discs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, month 3, 6, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, month 3, 6, and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
Functional Outcome by Oswestry Disability Index Questionnaire
Neurologic Status by Physical Exam
+3 moreOther study objectives
Health Economic - Duration of Hospitalization
Health Economic - Duration of Surgery
Health Economic - Return to Work
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MagnetOs Easypack PuttyExperimental Treatment1 Intervention
Interventions
* Procedure: Instrumented posterolateral spine fusion
* Device; MagnetOs Easypack Putty
Group II: Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft boneActive Control1 Intervention
Interventions
* Procedure: Instrumented posterolateral spine fusion
* Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone
Find a Location
Who is running the clinical trial?
Kuros BioSciences B.V.Industry Sponsor
3 Previous Clinical Trials
150 Total Patients Enrolled
Simplified Clinical Data Systems, LLCIndustry Sponsor
6 Previous Clinical Trials
174 Total Patients Enrolled
Kuros Biosurgery AGLead Sponsor
10 Previous Clinical Trials
781 Total Patients Enrolled
Henry Ford Health SystemOTHER
311 Previous Clinical Trials
2,176,333 Total Patients Enrolled
Cesar Silva, MDStudy DirectorKuros BioSciences B.V.
Pascal LongladeStudy DirectorKuros BioSciences B.V.
Katherine Sage, DOStudy DirectorKuros BioSciences B.V.