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 • ClinicalTrials.gov ID: NCT07225751
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Check Eligibility →Description
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.
Interventions
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MagnetOs
(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.
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Autograft
(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.
Eligibility criteria
Conditions
Locations
- University California Davis — Sacramento, California, United States
- Steadman Philippon Research Institute — Vail, Colorado, United States
- Hughston Foundation Inc — Columbus, Georgia, United States
- OrthoCarolina Research Institute, Inc — Charlotte, North Carolina, United States
- Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
- Integrity Orthopedics and Sports Medicine — Chattanooga, Tennessee, United States
- Centers for Advanced Orthopaedics — Falls Church, Virginia, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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