RecruitingNot ApplicableNCT07225751

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.

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

Enrollment

126 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Autograft and a medical device called MagnetOs for people with ankle arthrodesis or arthroplasty, ankle deformity, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetOs

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.

OTHERAutograft

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.


Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT07225751


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