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

Locations

5
Steadman Philippon Research Institute81657, VailColorado, United States
Hughston Foundation Inc31909, ColumbusGeorgia, United States
OrthoCarolina Research Institute, Inc28207, CharlotteNorth Carolina, United States
Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute19107, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

Kuros Biosurgery AG

Lead sponsor