Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Recruiting
N/A
Interventional Study
Degenerative Disc Disease
Spine Fusion
Back Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Kuros Biosurgery AG · Industry
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About This Trial
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 t…
Trial Locations
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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 arthrodes…
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