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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKuros Biosurgery AG

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.

Eligibility criteria

Qualifiers

Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.

Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old

Patients requiring one of the following hindfoot fusion procedures, using surgical technique, necessitating rigid hardware fixation and supplemental bone graft/ substitute: ankle fusion (tibiotalar) subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints).

Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • MagnetOs
  • Autograft

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators