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Ankle Arthrodesis or ArthroplastyBones and jointsDevice

What this study is

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.

What's being tested

  • MagnetOs

    Intervention · DEVICE

    MagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.

  • Autograft

    Intervention · OTHER

    In this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.

Study details

Official title
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
Sponsor
Kuros Biosurgery AG
Conditions
Ankle Arthrodesis or Arthroplasty · Hindfoot Fusion · Ankle Deformity · Ankle Disease · Hindfoot Arthrodesis · Hindfoot Pathologies
Enrolling
126 people
Starts
2025-11-25
Est. completion
2028-12
Design
Single-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗