A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.

Recruiting N/A Interventional Study
Ankle Arthrodesis or Arthroplasty Hindfoot Fusion Ankle Deformity Ankle Disease Hindfoot Arthrodesis Hindfoot Pathologies
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Kuros Biosurgery AG · Industry
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About This Trial

This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders. In this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.

Trial Locations
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Eligibility Criteria
Inclusion: 1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent. 2. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old 3. Patients requiring one of the following hindfoot fusion…
Contacts

Cesar Silva, MD

9702156793

cesar.silva@kurosbio.com

CONTACT